Regulatory Updates

FDA approved ANDA078511 submitted by PH HEALTH for two injectable Midazolam Hydrochloride products (1 mg/mL and 5 mg/mL), both listed as discontinued.

CARACO's ANDA078219 for oral escitalopram oxalate tablets (5 mg, 10 mg, 20 mg) has been granted tentative approval by the FDA.

Cipla Limited’s generic efavirenz 600 mg tablet has been granted tentative approval by the FDA under ANDA 077916.

The FDA has approved ANDA209610 for a prescription topical gel combining clindamycin phosphate (EQ 1.2% base) and benzoyl peroxide (3.75%). The product is marketed by Padagis Israel Pharmaceuticals Ltd.

FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.

The FDA has approved TOLSURA, an oral itraconazole 65 mg capsule from Mayne Pharma, under NDA208901 as a new formulation.

The FDA granted priority approval for SANOFI AVENTIS US's ORNIDYL injectable (Eflornithine Hydrochloride 200 mg/mL) under NDA019879, with orphan drug designation.

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 ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.

The FDA granted approval for Lupin Pharmaceuticals' prescription nasal spray containing 0.5 mg per spray of CYANOCOBALAMIN under ANDA210629.

FDA has approved ANDA 207417 for methylphenidate hydrochloride oral solution, 5 mg/5 mL and 10 mg/5 mL strengths, manufactured by Ascent Pharmaceuticals.

The FDA has approved ANDA207047 for an oral clindamycin palmitate hydrochloride solution (75 mg/5 ml) marketed by Heritage Pharmaceuticals under sponsor APPCO.