Dr. Reddy’s announces ANDA approval of Omeprazole Mg OTC
Dr. Reddy’s Laboratories (NYSE: RDY) announced on June 9, 2009 that the U.S. Food and Drug Administration has granted approval of the company’s Abbreviated New Drug Application (ANDA) for Omeprazole Mg OTC. Shipment of the product will be phased over the remainder of the fiscal year 2010 with the first shipment likely to commence in early Q2 of fiscal year 2010. Omeprazole Mg is indicated for the treatment of heartburn. Dr. Reddy’s formulation contains 20.6mg Omeprazole Mg and the dosage form is a capsule.
Source: Dr. Reddy’s