FDA Backtracks: 3 Generic Drugs Stay After Oopsie Correction
Published Date: 10/9/2026
Notice
Summary
The FDA fixed a previous announcement about pulling approval for 16 generic drug applications. Three drugs from Navinta LLC—ribavirin solution, fosaprepitant powder, and nicardipine capsules—won't lose approval because Navinta asked to keep them active. This means those three drugs stay on the market, while the other 13 still had their approvals withdrawn as planned back in July 2026.
Analyzed Economic Effects
2 provisions identified: 1 benefits, 1 costs, 0 mixed.
Three Navinta ANDAs remain approved
The FDA corrected a June 3, 2026 notice to state that Navinta LLC timely asked that approval not be withdrawn for ANDA 207366 (ribavirin solution, 6 grams/vial), ANDA 212957 (fosaprepitant dimeglumine powder, Equivalent to 150 mg base/vial), and ANDA 218638 (nicardipine HCl capsules, 20 mg and 30 mg). Those three ANDA approvals remain in effect as of the October 9, 2026 correction.
Thirteen other ANDA approvals withdrawn as planned
The June 3, 2026 notice announced withdrawal of approval for 16 ANDAs effective July 6, 2026; this correction removes three Navinta entries and leaves the other 13 ANDA approvals withdrawn as of July 6, 2026. Those 13 ANDA approvals remain withdrawn as previously announced.
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