Regulatory Updates

FDA granted approval for ANDA083089 covering two oral capsule strengths of propoxyphene hydrochloride by Roxane; both products are listed as discontinued.

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.

FDA records show a series of approved labeling and manufacturing supplemental applications for the discontinued LINDANE 1% topical lotion under ANDA 087313.

The FDA record shows SCANDONEST L injectable, containing levonordefrin and mepivacaine, has a discontinued marketing status and a history of approved labeling and manufacturing submissions dating from 1984 to 2018.

The FDA’s ANDA088071 filing shows that DEXAIR ophthalmic ointment, containing 0.05% dexamethasone sodium phosphate, is marked discontinued by sponsor PharmaFair.

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 approved ANDA077507, a generic oral tablet combining glipizide and metformin hydrochloride in three strengths, submitted by EPIC PHARMA LLC.

The FDA’s ANDA 077198 for alprazolam extended‑release tablets submitted by Actavis Labs FL Inc shows all listed products as discontinued.

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.

Amgen’s rare‑disease drug Tavneos faces added scrutiny after a leading medical journal retracted its pivotal study data, heightening FDA pressure.

The FDA approved ANDA077797 for prescription oral tablets of Cycbenzaprine Hydrochloride, 5 mg and 10 mg, manufactured by Solco Healthcare U.S., LLC and sponsored by Prinston Inc.