Opportunity
Federal Register #2026-11429
FDA Notice: Drug Products Not Withdrawn for Safety or Effectiveness Reasons
Buyer
Food and Drug Administration
Posted
June 08, 2026
Identifier
2026-11429
This FDA notice provides an update on the regulatory status of several drug products: - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - OEMs (Original Equipment Manufacturers) highlighted: - Eli Lilly and Co. - Hospira, Inc. - Pfizer Inc. - AbbVie Inc. - Merck Sharp & Dohme - Astellas Pharma US Inc. - Janssen Pharmaceuticals, Inc. - Additional manufacturers are referenced for specific products - Products/Drugs listed (examples): - Protamine Sulfate Intravenous Solution (Eli Lilly and Co.) - Methotrexate Sodium Injectable (Hospira, Inc.) - Taxotere Injectable (Docetaxel) - Tamiflu Capsule (Oseltamivir Phosphate) - Mycamine Injectable (Micafungin Sodium) - Fentora Tablet Buccal/Sublingual (Fentanyl Citrate) - Trilipix Capsule (Choline Fenofibrate) - Qtern Tablet (Dapagliflozin; Saxagliptin Hydrochloride) - Over 30 additional pharmaceuticals, including injectables, tablets, creams, ointments, and solutions - No specific purchase quantities or part numbers for procurement; products are referenced by NDA/ANDA numbers - Notable requirements: - FDA has determined these drugs have not been withdrawn for safety or effectiveness reasons - Allows continued approval of abbreviated new drug applications (ANDAs) referencing these products - Notice is informational and does not request procurement or announce an award
Description
The Food and Drug Administration (FDA) has determined that the drug products listed in this document, including Protamine Sulfate Intravenous Solution, 50 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination means FDA will not initiate procedures to withdraw approval of abbreviated new drug applications (ANDAs) referring to these products. The FDA will continue to approve ANDAs for these products as long as they meet relevant legal and regulatory requirements. The notice confirms that these products remain eligible for marketing despite being discontinued for reasons other than safety or effectiveness.