Opportunity
Federal Register #2026-20730
FDA correction keeps three Navinta drug application approvals in effect
Buyer
Department of Health and Human Services / Food and Drug Administration
Posted
October 09, 2026
Identifier
2026-20730
The FDA corrected a drug-approval notice to keep three Navinta LLC applications in effect; this is not a procurement request. - Government buyer: None. The notice was issued by the U.S. Department of Health and Human Services, Food and Drug Administration (FDA). - Navinta LLC is identified as the applicant that requested its approvals not be withdrawn; the notice does not identify a supplier or procurement vendor. - The three applications that remain approved cover: - Ribavirin solution, ANDA 207366: 6 grams per vial. - Fosaprepitant dimeglumine powder, ANDA 212957: equivalent to 150 mg base per vial. - Nicardipine hydrochloride capsules, ANDA 218638: 20 mg and 30 mg strengths. - No products or services are being requested for purchase, and no quantities for procurement are specified.
Description
The FDA is correcting its June 3, 2026 notice concerning the withdrawal of approval of 16 abbreviated new drug applications (ANDAs). The correction removes three Navinta LLC applications—ANDA 207366 for ribavirin solution, ANDA 212957 for fosaprepitant dimeglumine powder, and ANDA 218638 for nicardipine hydrochloride capsules—because Navinta timely requested that their approvals not be withdrawn. The approvals for those applications remain in effect.