Dr Reddy's Laboratories announced that the U.S. Food and Drug Administration (FDA) have determined the New Drug Application (NDA) submitted by the Company for Amlodipine Maleate as "approvable."

Final approval of the NDA is contingent upon the successful completion of ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labeling. Final approval is also contingent upon a successful outcome in the patent term extension litigation with Pfizer.

Commenting on the development, G V Prasad, CEO, Dr. Reddy's Laboratories said, "The issuance of this letter reflects achievement of a key milestone for Dr. Reddy's in its attempt to launch a specialty product in the US market. We are particularly pleased that our very first NDA was determined approvable by the FDA within 10 months. Contingent upon a successful outcome in the patent term extension litigation with Pfizer, we expect to launch Amlodipine Maleate on August 26, 2003."

Dr. Reddy's filed a New Drug Application (NDA) for Amlodipine Maleate under Section 505(b) (2) of the Federal Food, Drug and Cosmetic Act. Under the NDA, the Company had filed Paragraph IV certifications on the two Orange Book patents listed for Pfizer's Norvasc: the '909 and '303 patents.

On June 17, 2002, Pfizer notified Dr. Reddy's that it had filed a suit in the Federal Court in New Jersey on one of the two Orange Book patents, the '909 patent. Pfizer did not file a suit on the second patent. Subsequently, Dr Reddy's filed a motion for summary judgment and the motion is scheduled to be argued in mid-December 2002.

Amlodipine Besylate is the generic version of Pfizer's Norvasc and is indicated for the treatment of hypertension and angina.