Regulatory Updates

The FDA approved ANDA076609 for a 100 mg propoxyphene napyslate and 650 mg acetaminophen oral tablet submitted by Watson Labs Florida; the product is listed as discontinued.

The FDA has approved Sun Pharmaceutical's epoprostenol injectable (ANDA210473), covering 0.5 mg and 1.5 mg vial strengths for intravenous use.

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

The FDA approved Lupin’s injectable DOXERCALCIFEROL (4 mcg/2 ml) under ANDA210801; the product is listed as discontinued.

The FDA approved STEGLATRO, an oral ertugliflozin tablet (5 mg and 15 mg) from Merck Sharp & Dohme, NDA209803.

The FDA’s database shows several THORAZINE oral, rectal, and injectable products marked as discontinued, with a Federal Register note that discontinuations were not for safety or effectiveness reasons.

The FDA has approved application ANDA208756 submitted by Rhodes Pharm for oral dexmethylphenidate hydrochloride tablets in 2.5 mg, 5 mg and 10 mg strengths, though the products are listed as discontinued.

VARUBI, an intravenous rolapitant hydrochloride emulsion by TERSERA, received FDA approval (NDA 208399) with original submission in 2017 and labeling updates in 2018 and 2020; marketing status is discontinued.

The FDA has granted approval for LEUCOVORIN CALCIUM (application ANDA207241) manufactured by Fresenius Kabi USA for prescription use.

The FDA has approved the generic drug Sevelamer Hydrochloride (ANDA 206883) from Macleods Pharmaceuticals, available as 400 mg and 800 mg oral tablets.

The FDA has approved application ANDA090935 for oral prescription Warfarin Sodium tablets ranging from 1 mg to 10 mg, manufactured by Exelan Pharmaceuticals.

FDA has granted approval for ANDA090609, allowing Dr. Reddy's Laboratories to market generic atomoxetine hydrochloride oral capsules in multiple strengths.