Regulatorische Updates

The FDA has listed the oral prednisolone 5 mg tablet (product 001) from sponsor Bundy as discontinued under ANDA083675.

FDA records indicate that Watson Labs' injectable product COBAVITE, containing 1 mg/mL cyanocobalamin, is listed as discontinued under ANDA083064.

The FDA granted approval (ANDA080718) for BEL MAR's thiamine hydrochloride injectable product, listed as discontinued.

The FDA has approved ANDA078384 for carvedilol oral tablets (3.125‑25 mg) manufactured by Unichem Pharmaceuticals and sponsored by Regcon Holdings.

The FDA’s NDA007504 approval for ACTHAR injectable (25 UNITS/VIAL and 40 UNITS/VIAL) by Sanofi Aventis includes multiple priority labeling supplements, though the products are listed as discontinued.

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

The FDA has approved Hospira’s Metoprolol Tartrate injectable (ANDA078085), an intravenous prescription drug with a 1 mg/mL strength.

FDA has approved ANDA 077783 for oral lamotrigine tablets (25‑200 mg) submitted by Chartwell Molecular, with multiple labeling submissions cleared.

The FDA has approved the ANDA 077491 for Pravastatin Sodium tablets from Amici Pharma, covering strengths from 10 mg to 80 mg.

FDA records show the oral tablet MEPROBAMATE (400 mg) is discontinued, with multiple manufacturing and labeling submissions approved between 1983 and 1999.

DILOR-400, an oral tablet containing 400 mg theophylline, was approved under ANDA084751 with multiple manufacturing supplements; the product is currently discontinued.

The FDA approved ANDA 076335 for the oral tablet TRI-PREVIFEM, containing ethinyl estradiol and norgestimate, sponsored by PH HEALTH. The product is listed as discontinued.