Regulatory Updates

FDA has approved Teva Pharm’s methylphenidate hydrochloride extended‑release capsules in 10 mg, 20 mg and 30 mg strengths under ANDA 077707.

The FDA records show OxyMorphone Hydrochloride extended‑release tablets are discontinued, yet several labeling and REMS submissions for the product have been approved.

FDA granted approval for ANDA204552, an oral extended‑release capsule combining 25 mg aspirin and 200 mg dipyridamole, sponsored by Chartwell Molecular.

The FDA has granted approval for Sun Pharmaceutical Industries’ Zolpidem Tartrate extended‑release tablets (6.25 mg and 12.5 mg) under ANDA 204170.

The FDA has approved CARDIZEM CD, an extended‑release oral capsule of diltiazem hydrochloride (NDA020062), manufactured by Bausch Health US LLC.

The FDA approved labeling for Mylan's discontinued Nisoldipine extended‑release tablets (20 mg, 30 mg, 40 mg) under ANDA 079051.

FDA approved ANDA089116 for BROMPHERIL, an oral extended-release tablet containing 6 mg dexbrompheniramine maleate and 120 mg pseudoephedrine sulfate, submitted by Copley Pharm; product is listed as discontinued.

FDA granted labeling approvals for Torrent Pharm's discontinued Alfuzosin Hydrochloride 10 mg extended‑release tablet (ANDA 079054).

The FDA approved the original ANDA for Alprazolam extended‑release tablets (product numbers 001‑004) on Oct 15 2007, with a labeling supplement approved on Nov 29 2011. All four strengths (0.5 mg, 1 mg, 2 mg, 3 mg) are now listed as discontinued by sponsor PH Health.

The FDA has approved Sandoz's ANDA076873 for a prescription oral metformin hydrochloride 500 mg extended‑release tablet, with multiple labeling supplements approved.

The FDA has approved ANDA078889 for generic metoprolol succinate extended‑release tablets (100 mg and 200 mg) from several manufacturers.

Actavis Labs FL Inc received FDA approval for its metoprolol succinate extended‑release tablets under ANDA 076862, covering a prescription 50 mg product and a discontinued 25 mg product.