Regulatory Updates

The FDA approved Mylan's ANDA077486 for GLIMEPIRIDE tablets (1mg, 2mg, 4mg), though all listed products are marked as discontinued.

The FDA approved ANDA 084744 on Dec 9 1975 for Meprobamate tablets (200 mg and 400 mg) marketed by Parke Davis, now listed as discontinued.

Fierce Pharma’s 2026 regulatory tracker logs progress of in‑market products, noting geographic expansions and new indications, even when not full stories.

FDA records show multiple labeling and manufacturing submissions for LOESTRIN 21 1.5/30, a discontinued oral contraceptive tablet, with the latest activity in May 2022.

The FDA’s ANDA 087722 for LORTAB (acetaminophen 500 mg/hydrocodone 5 mg oral tablet) includes a series of approved manufacturing and labeling submissions from 1984 to 1999; the product is now discontinued.

Unicycive is optimistic its third‑party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.

The FDA has chosen seven firms, including Eli Lilly, Regeneron and Fujifilm, to join its PreCheck Pilot Program aimed at bolstering U.S. drug manufacturing and supply‑chain resilience.

The FDA approved Diprosone lotion, a topical betamethasone dipropionate product (0.05% base) under NDA 017781. It is listed as discontinued but not withdrawn for safety reasons.

The FDA has approved labeling submissions for Teva Pharm’s discontinued levetiracetam tablets (250 mg, 500 mg, 750 mg, 1 g) under ANDA078101.

Fierce Pharma’s H2 2026 Regulatory Tracker logs progress of existing products, noting geographic expansions and new indications, even when updates aren’t full stories.

The FDA record for NDA018082 lists DEPAKENE syrup as discontinued, with a Federal Register note that safety was not a factor, and details multiple labeling submissions from 1981 to 2016.

FDA records show B. Braun’s Dextrose 60% injectable products (NDA 017995) have been discontinued, with submission history dating back to 1978.