Regulatory Updates

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 ANDA206666 for Pentamidine Isethionate injectable, a prescription drug administered intramuscularly or intravenously.

The FDA approved ANDA083389 for a lidocaine hydrochloride 1% injection containing 0.01 mg/mL epinephrine, submitted by Dell Labs; the product is listed as discontinued.

The FDA’s ANDA089606 filing for Watson Labs’ prochlorperazine edisylate injectable is listed as discontinued, detailing route, dosage form, and active ingredient.

The FDA has listed the ANDA089249 application for NANDROLONE DECANOATE injectable by Quad Pharms as discontinued, noting its marketing status and product details.

SUN Pharma Global's ANDA077703 for injectable pamidronate disodium (30 mg and 90 mg vials) has been marked discontinued by the FDA.

The FDA has listed Quad Pharms' methotrexate sodium injection (product 001) as discontinued under ANDA089309.

The FDA approved ANDA080711 for a procaine hydrochloride injectable product by BEL MAR. The original submission was approved on Dec 3 1973 and the product is listed as discontinued.

FDA approved Abbott's Calcium Gluceptate injection (ANDA083159) in 1972, with a supplemental manufacturing amendment in 1984; the product is now discontinued.

FDA has approved Hikma's Granisetron Hydrochloride injectable (ANDA077177) with labeling updates in 2014 and 2022, confirming its prescription status.

The FDA has approved ANDA080712 for a thiamine hydrochloride injectable product by BEL MAR; the product is listed as discontinued.

Watson Labs' injectable dexamethasone sodium phosphate (product 001) is listed as discontinued per FDA ANDA083702 filing.