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FDA-TRACK: Biosimilar User Fee Act Procedural Response Goals Summary

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

FDA-TRACK: Biosimilar User Fee Act Meeting Goals Summary

The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Biosimilar User Fee Amendments of 2022 (BsUFA III), authorizes FDA to assess and collect fees for biosimilar biological products from October 2023 through September 2027. FDA dedicates these fees to expediting the review process for biosimilar biological products, facilitating the development of safe and effective biosimilar products for the American public.

FDA Qualifies First AI Drug Development Tool, Will Be Used in 'MASH' Clinical Trials

[12/8/2025] The U.S. Food and Drug Administration (FDA) has qualified the first AI drug development tool, the AI-Based Histologic Measurement of NASH (AIM-NASH), to help pathologists assess metabolic dysfunction-associated steatohepatitis (MASH) disease activity in clinical trials. This cloud-based tool helps pathologists score liver biopsy components, including fat infiltration (steatosis), inflammation (hepatocellular ballooning and lobular inflammation), and scarring (fibrosis) stage. MASH, a significant public health challenge affecting millions of Americans, is a severe form of metabolic-associated fatty liver disease that develops when fat buildup in the liver causes inflammation and scarring. MASH can lead to cirrhosis (severe liver scarring), hepatic decompensation (worsening of liver function), liver cancer, liver transplantation, or death. Currently in MASH clinical trials, multiple experts independently assess liver histology, a time-consuming process made complicated by variable scoring. AIM-NASH could help standardize histologic assessment and reduce the time and resources needed for MASH drug development. The AIM-NASH system uses AI algorithms to analyze images of liver biopsies and provides scores according to the NASH Clinical Research Network scoring system. The process keeps humans involved, as pathologists are fully responsible for final interpretation, reviewing the whole slide image and AIM-NASH outputs before accepting or rejecting the AI-generated scores. The qualification was based on comprehensive validation studies demonstrating that AIM-NASH-assisted comparisons to expert consensus were similar to individual pathologists’ comparisons to expert consensus.

FDA Approves First Generic Estradiol Vaginal Insert for Treatment of Moderate to Severe Dyspareunia

[December 8, 2025] The U.S. Food and Drug Administration today approved the first generic version of Imvexxy® (estradiol vaginal inserts). This approval will provide women additional options for access to treatment of moderate to severe dyspareunia (painful sexual intercourse), a symptom of vulvar and vaginal atrophy, due to menopause by delivering a low dose of estradiol directly to vaginal tissue. The generic estradiol vaginal inserts are bioequivalent to the reference listed drug Imvexxy® and are available in the same 4 mcg and 10 mcg strengths. Generic drugs undergo rigorous FDA review to ensure they meet the same standards for quality, strength, purity, and stability as brand-name drugs. Generic drugs also have the same active ingredient, dosage form, strength, route of administration, and conditions of use as the brand-name drug. Generic drugs typically cost less than brand-name drugs, providing significant cost savings for patients and the healthcare system. Healthcare providers should review the full prescribing information for complete safety and dosing information.

CDER Manual of Policies & Procedures | MAPP

CDER's Manual of Policies and Procedures (MAPPs) are federal directives and documentation of internal policies and procedures. MAPPs are required by law and made available to the public to make CDER a more transparent organization. A MAPP may be removed from this FDA.gov page while it is being evaluated and updated. For more information about MAPPs, please contact the CDER MAPP Team: CDERMAPPTEAM@fda.hhs.gov This page contains the current CDER Manual of Policies and Procedures (MAPPs) in Adobe Acrobat Format (PDF). Please note that due to a CDER-wide initiative to update MAPPs, MAPPs may be removed for revision, recertification, or cancellation. Thank you for your patience.

Generic Drug Research Priorities & Projects

Each year, FDA consults with industry and the public to develop a list of regulatory science initiatives on generic drugs in accordance with the Generic Drug User Fee Amendments (GDUFA). These priorities are discussed and developed in public meetings and workshops and result in several awarded projects each year. Research Priorities FY 2026 GDUFA Science and Research Priorities (PDF - 139 KB) FY 2025 GDUFA Science and Research Priorities (PDF - 145 KB) FY 2024 GDUFA Science and Research Priorities (PDF - 126 KB) FY 2023 GDUFA Science and Research Priorities (PDF - 153 KB) FY 2022 GDUFA Science and Research Priorities (PDF – 143 KB) FY 2021 GDUFA Science and Research Priorities (PDF – 123 KB) FY 2020 GDUFA Science and Research Priorities (PDF – 107 KB) FY 2019 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2018 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2017 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2016 GDUFA Science and Research Priorities (PDF – 116 KB) FY 2015 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2014 GDUFA Science and Research Priorities (PDF – 113 KB) FY 2013 GDUFA Science and Research Priorities (PDF – 113 KB) GDUFA Regulatory Science Initiatives Public Workshops & Meetings FY2025 Generic Drug Regulatory Science Initiatives Public Workshop (June 3-4, 2025) FY2024 Generic Drug Regulatory Science Initiatives Public Workshop (May 20-21, 2024) FY2023 Generic Drug Regulatory Science Initiatives Public Workshop (May 11-12, 2023) FY2022 Generic Drug Regulatory Science Initiatives Public Workshop (May 9-10, 2022) FY2021 Generic Drug Regulatory Science Initiatives Public Workshop (June 23, 2021)​ FY 2020 Generic Drug Regulatory Science Initiatives Public Workshop (May 4, 2020) FY 2019 Generic Drug Regulatory Science Initiatives Public Workshop (May 1, 2019) FY 18 Generic Drug Research Public Workshop (May 24, 2018) FY 2017 Generic Drug Research Public Workshop (May 3, 2017) FY 2016 Regulatory Science Initiatives Part 15 Public Meeting (May 20, 2016) FY 2015 Regulatory Science Initiatives Part 15 Public Meeting (June 5, 2015) FY 2014 Regulatory Science Initiatives Part 15 Public Meeting (May 16, 2014) FY 2013 Regulatory Science Initiatives Part 15 Public Meeting (June 21, 2013) Awarded Projects FY 2024 Awarded GDUFA Science and Research Contracts and Grants (PDF - 162 KB) FY 2023 Awarded GDUFA Science and Research Contracts and Grants (PDF - 173 KB) FY 2022 Awarded GDUFA Science and Research Contracts and Grants (PDF - 160 KB) FY 2021 Awarded GDUFA Science and Research Contracts and Grants (PDF – 197 KB) FY 2020 Awarded GDUFA Science and Research Contracts and Grants (PDF – 182 KB) FY 2019 Awarded GDUFA Science and Research Contracts and Grants (PDF – 182 KB) FY 2018 Awarded GDUFA Science and Research Contracts and Grants (PDF – 196 KB) FY 2017 Awarded GDUFA Science and Research Contracts (PDF – 98 KB) FY 2016 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) FY 2015 Awarded GDUFA Science and Research Contracts and Grants (PDF – 143 KB) FY 2014 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) FY 2013 Awarded GDUFA Science and Research Contracts and Grants (PDF – 98 KB) GDUFA Implementation Bi-Annual Industry Regulatory Science Working Group Meeting - November 17, 2025 Bi-Annual Industry Regulatory Science Working Group Meeting - August 6, 2025 Bi-Annual Industry Regulatory Science Working Group Meeting - October 30, 2024 Bi-Annual Industry Regulatory Science Working Group Meeting - August 28, 2024 Bi-Annual Industry Regulatory Science Working Group Meeting - November 17, 2023 Bi-Annual Industry Regulatory Science Working Group Meeting - August 30, 2023 Bi-Annual Industry Regulatory Science Working Group Meeting - December 8, 2022 Bi-Annual Industry Regulatory Science Working Group Meeting - March 23, 2022 Bi-Annual Industry Regulatory Science Working Group Meeting - September 24, 2021 Bi-Annual Industry Regulatory Science Working Group Meeting - March 12, 2021 Bi-Annual Industry Regulatory Science Working Group Meeting - February 10, 2020 Bi-Annual Industry Regulatory Science Working Group Meeting - September 17, 2019 Bi-Annual Industry Regulatory Science Working Group Meeting - February 25, 2019 Bi-Annual Industry Regulatory Science Working Group Meeting - November 1, 2018 Bi-Annual Industry Regulatory Science Working Group Meeting - April 10, 2018

Counterfeit Medicine

Report a counterfeit drug to FDA Counterfeit (fake or falsified) medicines may be harmful to your health because while being passed off as authentic, may contain the wrong ingredients, contain too much, too little or no active ingredient at all or contain other harmful ingredients. The U.S. drug supply is among the safest in the world. The U.S. has federal and state laws that create a “closed” drug distribution system to help ensure the U.S. drug supply is safe. FDA remains vigilant in protecting the U.S. drug supply from counterfeits drugs. However, there has been an increase in overdose deaths that are related to fentanyl-laced counterfeit drugs. Visit Overdose Prevention Framework and CDC’s Drug Overdose Deaths with Evidence of Counterfeit Pill Use for more information. FDA takes reports of suspect counterfeits seriously and works closely with other federal agencies and the private sector to help protect the nation's drug supply. Possible Signs of Counterfeit Drugs Health care providers and consumers need to be aware of how they could be exposed to counterfeit medicines. Watch out for possible signs of a counterfeit drug: Does the drug or packaging look different than what you normally receive? Have you experienced a new or unusual side effect after using the drug? Did you buy the drug from an online pharmacy? Consumers, health care providers and supply chain stakeholders should only buy from state-licensed pharmacies to ensure you are getting safe, effective and high-quality drugs that have been approved by FDA. Visit BeSafeRx for more information about the potential dangers of buying medicine from online pharmacies. Reports of Counterfeit Drugs Companies report counterfeit drugs to FDA, and the agency provides this information to consumers: FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain (Dec. 21, 2023; updated April 14, 2025; updated Dec. 5, 2025) Haleon: Consumers should not use counterfeit alli (orlistat) capsules found at U.S. online retailers (June 20, 2025) Counterfeit version of Botox found in multiple states (April 16, 2024) Novo Nordisk Warns Consumers about Counterfeit Ozempic (semaglutide) injection 1 mg in the U.S. (December 21, 2023) Novo Nordisk warns of counterfeit Ozempic (semaglutide injection) pen found in U.S. (June 16, 2023) Bausch + Lomb: Counterfeit Versions of Muro 128 (Sodium Chloride Hypertonicity Ophthalmic Ointment, 5%) and Muro 128 (Sodium Chloride Hypertonicity Ophthalmic Solution, 5%) Found in the U.S. (April 25, 2023) Report Suspected Unsafe Products to FDA Report sales of medicine by unsafe online pharmacies to the FDA Report adverse effects caused by any medicine to FDA’s MedWatch program Report suspected criminal counterfeit activity to FDA’s Office of Criminal Investigations Global Perspective Many counterfeit drugs are made abroad and arrive in the U.S. through the mail or are smuggled into the country. FDA works with U.S. Customs and Border Protection and focuses on areas that present the most substantial threat to our drug supply. Drug safety and quality do not begin or end at the U.S. border. The U.S. government works with foreign regulatory counterparts, when possible, to disrupt or close illegal operations involving the production and distribution of counterfeit drugs. Visit Centers for Disease Control and Prevention’s counterfeit medicines for helpful safety tips when traveling abroad. FDA Actions to Protect Against Counterfeit Drugs Works with industry and stakeholders to create a tighter, closed prescription drug distribution system to prevent harmful drugs from entering the supply chain, detect harmful drugs if they do enter the supply chain, and enable rapid response when such drugs are found. Electronically screens FDA-regulated drugs imported into the U.S. to ensure imported drugs must meet FDA’s rigorous standards for quality, safety and effectiveness as drugs made in the U.S. FDA’s Office of Criminal Investigations conducts criminal investigations of illegal activities involving FDA-regulated products, arresting those responsible and bringing them before the Department of Justice for prosecution. This includes activities such as cybercrime and distributing counterfeit, unapproved and misbranded drugs. Related Information Drug Supply Chain Security Act (DSCSA) | FDA Department of Justice / Drug Enforcement Agency: Counterfeit Pill Fact Sheet Federal Trade Commission: Buying Prescription Drugs Online Centers for Disease Control and Prevention: counterfeit medicines Questions Email druginfo@fda.hhs.gov Call 855-543-3784 or 301-796-3400 Email the FDA Internet Pharmacy Task Force FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov

Generic Drugs Program Fiscal Year 2025 Activities Report

Original ANDA ReviewStandard Original ANDA Submissions10 months29 of 40097%7% to 99%100%7% to 100%Priority Original ANDA Submissions (if applicant meets requirements of a PFC)8 months5 of 18100%28% to 100%100%28% to 100%Priority Original ANDA Submissions (if applicant does not meet the requirements of a PFC)10 months5 of 66100%8% to 100%100%8% to 100%Standard and Priority Original Facility not Ready with Reset30 months----------Amendment ReviewStandard Major ANDA Amendments (if PAI is not required)8 months167 of 51395%31% to 98%98%32% to 99%Standard Major ANDA Amendments (if PAI is required)10 months2 of 8100%25% to 100%100%25% to 100%Priority Major ANDA Amendments (if PAI is not required)6 months41 of 88100%47% to 100%100%47% to 100%Priority Major ANDA Amendments (if PAI is required and applicant meets the requirements of a PFC)8 months----------Priority Major ANDA Amendments (if PAI is required and applicant does not meet the requirements of a PFC)10 months----------Standard and Priority Minor ANDA Amendments3 months485 of 74686%58% to 91%98%64% to 99%PAS Review Time GoalsStandard PAS (if PAI is not required)6 months973 of 168599%57% to 99%99%58% to 99%Standard PAS (if PAI is required)10 months6 of 25100%24% to 100%100%24% to 100%Priority PAS (if PAI is not required)4 months89 of 11896%74% to 97%99%75% to 99%Priority PAS (if PAI is required and applicant meets the requirements of a PFC)8 months0 of 1--------Priority PAS (if PAI is required and applicant does not meet the requirements of a PFC)10 months1 of 3100%33% to 100%100%33% to 100%PAS Amendment Review Time GoalsStandard Major PAS Amendment (if PAI is not required)6 months51 of 102100%50% to 100%100%50% to 100%Standard Major PAS Amendment (if PAI is required)10 months0 of 1--------Priority Major PAS Amendment (if PAI is not required)4 months8 of 1188%64% to 91%100%73% to 100%Priority Major PAS Amendment (if PAI is required and applicant does not meet the requirements of a PFC)10 months----------

GDUFA III Reauthorization

Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the scope of regulating the generic drug industry. GDUFA was reauthorized on September 30, 2022 (GDUFA III), with provisions that are in effect from October 1, 2022, through September 30, 2027. The webpages listed below, along with the GDUFA III commitment letter, feature information about GDUFA III implementation activities and provide transparency on the progress and performance of FDA’s generic drugs program. These pages include recorded presentations, policy documents and other resources that highlight program changes, enhancements and new information in GDUFA III for current and prospective abbreviated new drug application (ANDA) applicants and others interested in generic drug development and regulation. These pages will be updated as more information becomes available throughout the implementation of GDUFA III. Pre-ANDA Program ANDA Assessment Program Controlled Correspondence Drug Master File (DMF) Assessments Changes for Facilities User Fee Resource Management Program Monthly and Quarterly Activities Report Generic Drugs Program FY 2025 Activities Report Generic Drugs Program FY 2024 Activities Report Generic Drugs Program FY 2023 Activities Report Questions about GDUFA III? Current and prospective ANDA applicants should contact genericdrugs@fda.hhs.gov. All others with inquiries should contact druginfo@fda.hhs.gov. Related Resources Generic Drug User Fee Amendments GDUFA Guidances and MAPPs ANDA Forms and Submission Requirements Pre-ANDA Program for Complex Generic Products GDUFA II Videos and Resources Reauthorization Information

FDA Rare Disease Innovation Hub

Fundamental to the mission of the U.S. Food and Drug Administration is to engage patients and caregivers – to understand their unique perspectives and experiences and keep these front of mind as we review medical products for rare disease patients. An estimated 10,000+ rare diseases affect more than 30 million people – approximately one out of every 10 people – in the U.S., and about half of these people are children. Many rare diseases and conditions are life threatening, and most do not have approved treatments. FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between Center for Biologics Evaluation and Research (CBER) and Center for Drug Evaluation and Research (CDER) with the goal of ultimately improving outcomes for patients. Although the Hub will work across rare diseases, it will particularly focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood. The Hub is co-led by the directors of Center for Biologics Evaluation and Research (CBER) and the FDA’s Center for Drug Evaluation and Research (CDER), in close collaboration with the FDA’s Center for Devices and Radiological Health, Oncology Center of Excellence, Office of Orphan Products Development, and Office of Combination Products. Connect with the Hub RDInnovationHub@fda.hhs.gov Resources CBER Rare Disease Program CDER’s Accelerating Rare disease Cures (ARC) Program FDA Voices: FDA Takes Exciting Steps Toward Establishing the Rare Disease Innovation Hub FDA Voices: FDA Rare Disease Innovation Hub to Enhance and Advance Outcomes for Patients Public Meeting: Advancing Rare Disease Therapies Through an FDA Rare Disease Innovation Hub Key Meeting Themes

Food and Drug Omnibus Reform Act (FDORA) of 2022

Reports Mandated by FDORA The Food and Drug Omnibus Reform Act of 2022 (FDORA) requires FDA to develop several different kinds of informational documents, including public reports, reports to Congress, strategic plans, and others. FDA will post those items here as they become available. FDORA Reports Real-World Evidence in COVID-19 Applications Report to Congress | December 2025 (PDF - 136 KB) Workshop Report: Enhancing Clinical Study Diversity | June 2024 (PDF - 624 KB) Meeting Report: Mitigating Clinical Study Disruptions During Disasters and Public Health Emergencies | January 2024 (PDF - 279 KB)

Upcoming EL-PFDD Meetings

To promote transparency and communication, FDA is sharing a list of disease areas where a letter of intent (LOI) has been submitted and ongoing plans exist for a future Externally-Led PFDD meeting. While multiple organizations may be working together, the organizations listed below are the primary points of contact for any questions regarding their EL-PFDD meeting. FDA does not conduct Externally-Led PFDD meetings and a listing on this webpage does not reflect endorsement. Questions? To contact FDA’s CDER Patient-Focused Drug Development Program Staff, please email patientfocused@fda.hhs.gov. To get updates about CDER’s Patient-Focused Drug Development programs, subscribe to our free email subscription service at the bottom of the page.

FDA warns consumers not to use counterfeit Ozempic (semaglutide) found in U.S. drug supply chain

Español Report a problem with a product to FDA [12/5/2025] FDA recently seized dozens of units of counterfeit Ozempic (semaglutide) injection 1 mg that were distributed illegally outside of Novo Nordisk's authorized supply chain. The seized counterfeit products were in the legitimate U.S. drug supply chain. The counterfeit products are labeled with lot number - PAR1229 - which also is an authentic lot number. The counterfeit products labeled with lot number PAR1229 can be identified by the location of the EXP/LOT text on the pen's label. The counterfeit product has the EXP/LOT text on the left side of the expiration date and lot number, while the authentic Ozempic pen contains the EXP/LOT text above the expiration date and lot number. Authentic vs. counterfeit pen Patients should not use Ozempic if the EXP/LOT text appears on the left side of the expiration date and lot number on the pen's label. Patients who received Ozempic injection 1mg with lot number PAR1229 through the Novo Nordisk Patient Assistance Program may continue using the product as it is authentic Ozempic. Recommendations for patients, retailers, wholesalers and health care professionals FDA advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not use, distribute or sell products that contain the counterfeit information above. The agency is aware of six adverse event reports associated with this lot. However, these adverse events are associated with authentic Ozempic and none of them appear to be associated with the counterfeit product. All six adverse events were reported by Novo Nordisk. FDA urges retail pharmacies to only purchase authentic Ozempic through authorized distributors of Novo NordiskExternal Link Disclaimer and review the product and information to confirm the legitimacy of their shipments. Pharmacists with concerns about whether their batches are authentic should contact Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. EST. Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting. FDA's ongoing investigation Testing and analysis of the seized products are underway to determine the drug's composition and safety risks. FDA was notified by Novo Nordisk on Nov. 18, 2025, that counterfeit Ozempic injection 1mg was in the legitimate U.S. drug supply chain. FDA's investigation is ongoing, and the agency is working to protect the U.S. drug supply. The agency takes reports of possible counterfeit medicines seriously and works closely with other federal agencies and the private sector to help protect the nation's drug supply. FDA is working with Novo Nordisk to identify, investigate and remove further suspected counterfeit Ozempic injectable products found in the U.S. Visit Novo Nordisk's announcement for more information. Report adverse events Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online at MedWatch Online Voluntary Reporting Form or Download and complete the form, then submit it via fax at 1-800-FDA-0178. [4/14/2025] FDA was notified by Novo Nordisk on April 3, 2025, that several hundred units of counterfeit Ozempic (semaglutide) injection 1mg were in the U.S. drug supply chain. The counterfeit products were distributed outside the Novo Nordisk authorized supply chain in the U.S. FDA seized the identified counterfeit products on April 9, 2025. The agency advises patients, wholesalers, retail pharmacies and health care professionals to check the Ozempic products they have received and not use, distribute or sell products labeled with lot number PAR0362 and serial number starting with the first eight digits 51746517 as pictured below. FDA is aware of six adverse event reports associated with this lot, however none of them appear to be associated with the counterfeit product. All six adverse events were reported by Novo Nordisk. FDA and Novo Nordisk are testing the seized products and do not yet have information about the identity, quality or safety of these drugs. FDA’s investigation is ongoing, and the agency is working to protect the U.S. drug supply. Visit Novo Nordisk’s announcement for more information. Report a problem with a product to FDA. [12/21/2023] FDA continues to investigate counterfeit Ozempic (semaglutide) injection 1 milligram (mg) in the legitimate U.S. drug supply chain and has seized thousands of units of the product. The agency advises wholesalers, retail pharmacies, health care practitioners and patients to check the product they have received and not distribute, use, or sell products labeled with lot number NAR0074 and serial number 430834149057 as pictured below. Some counterfeit products may still be available for purchase. FDA and Novo Nordisk (manufacturer of Ozempic) are testing the seized products and do not yet have information about the drugs’ identity, quality, or safety. Additionally, analysis found the needles from the samples are counterfeit. Accordingly, the sterility of the needles cannot be confirmed, which presents an increased risk of infection for patients who use the counterfeit products. Based on analyses completed to date, other confirmed counterfeit components within the seized products are the pen label, accompanying health care professional and patient information, and carton. FDA is aware of five adverse events from this lot, none of which are serious and are consistent with known common adverse reactions to authentic Ozempic, which are nausea, vomiting, diarrhea, abdominal pain and constipation. FDA recommends retail pharmacies only purchase authentic Ozempic through authorized distributors of Novo Nordisk and review the photographs and information to confirm the legitimacy of their shipments. Patients should only obtain Ozempic with a valid prescription through state-licensed pharmacies and check the product before using for any signs of counterfeiting. FDA takes reports of possible counterfeit products seriously and works closely with other federal agencies and the private sector to help protect the nation’s drug supply. FDA’s investigation is ongoing, and the agency is working with Novo Nordisk to identify, investigate, and remove further suspected counterfeit semaglutide injectable products found in the U.S. Health care professionals and consumers should report adverse events or side effects related to the use of this product to FDA’s MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report online at MedWatch Online Voluntary Reporting Form or Download and complete the form, then submit it via fax at 1-800-FDA-0178. Entities, including online sellers, selling counterfeit and/or tampered medicines should be reported to FDA. Suspected counterfeit products may be reported to FDA by calling your local FDA consumer complaint coordinator or by reporting it directly at report suspected criminal activity. Retailers and patients may also contact Novo Nordisk customer care at 1-800-727-6500 Monday through Friday from 8:30 a.m. to 6 p.m. ET with questions or concerns. Visuals of authentic and counterfeit needles are shown below: More Information:

Drug Trials Snapshot: LYNOZYFIC

LYNOZYFIC (linvoseltamab-gcpt) lin-oh-ZI-fik Regeneron Pharmaceuticals, Inc. Original Approval date: July 2, 2025 DRUG TRIALS SNAPSHOT SUMMARY: What is the drug for? LYNOZYFIC is a bispecific antibody used to treat a type of cancer called multiple myeloma. LYNOZYFIC is indicated for adults whose cancer has come back after, or not responded to, at least four prior treatment regimens including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody (mAb). This is called relapsed or refractory disease. How is this drug used? LYNOZYFIC is given as an infusion through a vein by a healthcare provider. A process called step up dosing is used where the first dose is low dose. This is done to evaluate how well the patient tolerates the drug before the first full-strength dose is administered. Patients who receive LYNOZYFIC will be hospitalized for 24 hours after receiving each of the first two step up doses to be closely monitored for side effects. After completing these two doses, patients will receive full doses once a week. Who participated in the clinical trial? The FDA approved LYNOZYFIC based on the safety and efficacy data from a single clinical trial (Study R5458-ONC-1826). A total of 117 patients who received the full dose of the drug (200 mg) were included in the safety analysis population. The efficacy population included 80 patients who received the full dose and had at least four prior lines of therapy for their disease. The patients in the efficacy population were treated in five countries including Belgium, Germany, Spain, Korea, and the United States. A total of 77% of patients were enrolled at study sites in the United States. A total of 22% of patients were enrolled at sites outside the United States (Europe 11% and Asia 11%). Males comprised 64% of the total efficacy population. Regarding the race of patients in the United States study population, 77% were White, 12% were Black or African American, 1% Asian, and 2% were identified as “other” or not reported. Only 2% of United States patients identified their ethnicity as Hispanic. The average age of the patients was 63 years old (range 37 to 83 years). How were the trials designed? The R5458-ONC-1826 clinical trial was a phase 1/2 single-arm study of LYNOZYFIC monotherapy (given alone) in patients with relapsed or refractory multiple myeloma. Phase 1 was the dose escalation portion to determine the appropriate dosing and learn about the side effects of the drug. Phase 2 included two groups (“cohorts”) to evaluate the efficacy of the proposed dose. All study patients received LYNOZYFIC until their disease progressed or the side effects became too toxic. The benefit and effectiveness of LYNOZYFIC was measured by the proportion of patients that achieved a clinically relevant improvement in their disease (overall response rate; ORR) based on standard response criteria and how long the response lasted (duration of response; DOR). DEMOGRAPHICS SNAPSHOT Figure 1 summarizes how many male and female patients were enrolled in the clinical trial used to evaluate the efficacy of LYNOZYFIC. Figure 1. Baseline Demographics by Sex, Efficacy Population Source: Adapted from FDA Review Figure 2 summarizes how many patients by race were enrolled in the clinical trial used to evaluate the efficacy of LYNOZYFIC. Figure 2. Baseline Demographics by Race, Efficacy Population Source: Adapted from FDA Review Figure 3 summarizes how many patients by age were enrolled in the clinical trial used to evaluate the efficacy of LYNOZYFIC. Figure 3. Baseline Demographics by Age, Efficacy Population Source: Adapted from FDA Review Figure 4 summarizes how many patients by ethnicity were enrolled in the clinical trial used to evaluate the efficacy of LYNOZYFIC. Figure 4. Baseline Demographics by Ethnicity, Efficacy Population Source: Adapted from FDA Review What are the benefits of this drug? The benefit of LYNOZYFIC was measured by the proportion of patients that achieved a clinically relevant improvement in their disease (ORR). Response was analyzed using the International Myeloma Working Group (IMWG) Criteria. The ORR was 70%. Were there any differences in how well the drug worked in clinical trials among sex, race, and age? Sex: The observed effect of LYNOZYFIC was larger in females than males. Because of the limited number of patients, this difference may be due to chance. Race: Most patients were White. Differences in effectiveness among races could not be determined because of the small number of patients in other races. Age: No overall differences in effectiveness of LYNOZYFIC were observed in patients of different age groups. What are the possible side effects? Side effects of LYNOZYFIC were evaluated in the safety population consisting of 117 patients who received the full dose (200 mg). The most common adverse reactions (≥20%) were musculoskeletal pain, cytokine release syndrome (CRS), cough, diarrhea, upper respiratory tract infection, fatigue, pneumonia, nausea, and headache. The most common National Cancer Institute Common Toxicology Criteria (NCI CTC) Grade 3 or 4 laboratory abnormalities (≥30%) were decreased lymphocytes, decreased neutrophils, decreased hemoglobin, and decreased white blood cells. Serious adverse events occurred in 74% of patients. Adverse events leading to dose interruption occurred in 71% of patients, most commonly neutrophil decrease, and infections. Adverse events leading to treatment discontinuation occurred in 16%, most commonly infections. The key safety concerns for LYNOZYFIC are CRS and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). CRS and neurologic toxicity were common occurrences in the safety population, occurring in 46% and 54% of patients, respectively. A boxed warning for both events has been incorporated in the LYNOZYFIC U.S. Prescribing Information (USPI). Other safety concerns identified in the USPI Warnings and Precautions section include infections, low neutrophil count (neutropenia), and liver disorders (hepatotoxicity). Were there any differences in how well the drug worked in clinical trials among sex, race, and age? Sex: No overall differences in side effects of LYNOZYFIC were observed between females and males. Race: All patients experienced similar side effects regardless of race. Age: No overall differences in safety or effectiveness were observed in patients of different age groups. GLOSSARY CLINICAL TRIAL: Voluntary research studies conducted in people and designed to answer specific questions about the safety or effectiveness of drugs, vaccines, other therapies, or new ways of using existing treatments. COMPARATOR: A previously available treatment or placebo used in clinical trials that is compared to the actual drug being tested. EFFICACY: How well the drug achieves the desired response when it is taken as described in a controlled clinical setting, such as during a clinical trial. PLACEBO: An inactive substance or “sugar pill” that looks the same as, and is given the same way as, an active drug or treatment being tested. The effects of the active drug or treatment are compared to the effects of the placebo. SUBGROUP: A subset of the population studied in a clinical trial. Demographic subsets include sex, race, and age groups. LINK TO DRUG PACKAGE INSERT

Over-the-Counter OTC | Nonprescription Drugs

On June 27, 2022, the FDA announced the availability of the proposed rule Nonprescription Drug Product with an Additional Condition for Nonprescription Use (Docket No. FDA-2021-N-0862). The proposed rule is intended to increase options for the development and marketing of safe and effective nonprescription drug products, which could improve public health by broadening the types of nonprescription drug products available to consumers. For more information, see The FDA Announces Proposed Rule: Nonprescription Drug Product with an Additional Condition for Nonprescription Use. On March 27, 2020, the President signed the Over-the-Counter Monograph Safety, Innovation, and Reform Act into law. This act is intended to modernize the process by which FDA regulates over-the-counter monograph drugs. The FDA is in the process of implementing the changes set forth in the act and will update the public and this webpage as we have additional information.