Regulatory Updates

The FDA’s database lists ANDA 077944 for meloxicam tablets (7.5 mg and 15 mg) by Lupin Pharmaceuticals, with several labeling submissions approved; the products are currently marked discontinued.

FDA has approved ANDA077655 for valacyclovir hydrochloride oral tablets (500 mg and 1 g) from Teva Pharm, with original and supplemental labeling approvals.

The FDA has approved ANDA 077351, covering a range of oral acid‑reducer and heartburn‑prevention products listed under various brand names.

SUN PHARM received FDA approval for ANDA077058 covering Pantoprazole Sodium delayed‑release tablets (20 mg and 40 mg). Multiple labeling supplements were approved between 2009 and 2015.

The FDA has approved several labeling supplement submissions for discontinued oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) under ANDA 076765.

The FDA issued an approval letter for ANDA 076484 submitted by Fresenius Kabi USA, covering two ciprofloxacin injectable products (200 mg/20 mL and 400 mg/40 mL). Both products are listed as discontinued.

The FDA has approved Apotex’s generic sotalol hydrochloride tablets (80 mg, 120 mg, 160 mg) under ANDA 076214, with labeling updates through 2023.

The FDA has granted approval for ANDA080445, covering multiple injectable strengths of meperidine hydrochloride manufactured by Hikma Pharmaceuticals USA.

FDA issued a Complete Response Letter for HLB’s ribociclib NDA, citing cGMP deficiencies at the Chinese Hengrui manufacturing site.

Korea’s MFDS is drafting a change order for mycophenolate and albendazole drug labels, incorporating safety findings from the US FDA and EU EMA, and has opened a public comment period.

FDA approved Hikma's ANDA 079217 for oral Dronabinol capsules (2.5 mg, 5 mg, 10 mg); all listed products are currently marked discontinued.

FDA has approved ANDA078898 for Zydus Pharm's oral galantamine hydrobromide tablets (4 mg, 8 mg, 12 mg) with standard labeling submissions.