Regulatory Updates

Laurus Labs Ltd filed a Type 4 New Combination NDA (213696) with the FDA, recorded as a standard priority original submission on Jan 25 2022.

The FDA has approved NDA017579 for RETIN-A, a prescription 0.025% tretinoin topical gel marketed by Bausch Health US and Mylan Pharmaceuticals.

FDA approved Roche's injectable NIPRIDE (sodium nitroprusside 50 mg/vial) under NDA 017546 in 1974; the product is now discontinued after multiple labeling updates.

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.

FDA approved NDA017780 for PHARM SPEC's Heparin Sodium injectable products, listing five strengths now marked discontinued.

The FDA NDA 007883 for Antabuse lists two discontinued tablet strengths and a series of priority supplemental submissions for manufacturing and labeling, all approved.

FDA has approved NDA007392 for Seconal Sodium injectable, a secobarbital sodium product by Lilly, with a detailed submission history and discontinued marketing status.

FDA NDA017406 for DICOPAC KIT, sponsored by GE Healthcare, indicates the product is discontinued and lists its submission history and active ingredients.

The FDA approved ECONOPRED, a 0.125% prednisolone acetate ophthalmic suspension, under NDA 017468 with multiple manufacturing submissions and a 2003 labeling approval. The product is now 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.