Regulatorische Updates

FDA approved several manufacturing and labeling submissions for Prilosec (omeprazole) products under NDA 019810, including priority reviews for 10 mg, 20 mg and 40 mg strengths.

The FDA has approved a series of labeling and manufacturing submissions for the discontinued CYCLOCORT cream, noting no safety concerns.

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.

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.

Sun Pharm Industries received FDA approval for an ANDA (ANDA081029) covering oral quinidine sulfate tablets (100 mg). The product is listed as discontinued, with multiple supplemental approvals for manufacturing and labeling.

Daewoong Bio is redesigning packaging for its entire prescription line to improve visual identification and reduce compounding errors, aligning with the MFDS’s July push for safer drug labeling.

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

The FDA approved application ANDA080531 for a 5 mg oral prednisolone tablet marketed by Chartwell RX, LLC, with multiple manufacturing and labeling supplements authorized.

FDA has approved ANDA077099 for ORSYTHIA, an oral tablet containing ethinyl estradiol 0.02 mg and levonorgestrel 0.1 mg, sponsored by PH Health.

The FDA has approved ANDA078299 for Ketorolac Tromethamine injectable (15 mg/mL and 30 mg/mL) from Onesource Specialty, with labeling updates; both products are marked discontinued.