Regulatory 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.

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.

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

Lotte Biologics announced on the 22nd that its Phase‑1 facility at Incheon’s Songdo Bio Campus has received use approval, marking completion of major construction within about two years.

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 labeling and manufacturing submissions for ISOPAQUE 280, an injectable calcium, meglumine, and metrizoic acid product, under NDA 017506.

FDA records approval of a supplemental manufacturing (CMC) submission for ANDA 086178, covering the oral GLYCOPYRROLATE 2 mg tablet by Watson Labs, now listed as discontinued.

The FDA has put Sobi's planned gout medication on hold, delaying its challenge to Amgen's Krystexxa.

The FDA has approved ANDA084306 for MYDRIACYL, a 1% tropicamide ophthalmic solution marketed by Alcon Laboratories.

The FDA record for NDA 008048 shows XYLOCAINE ointment, a discontinued 5% lidocaine topical, received multiple approved manufacturing and labeling submissions from 1984 to 1996.