The final approval of NDA is contingent upon a successful outcome in the patent term extension litigation with drug major Pfizer. The approval is also contigent upon the successful completion of ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labeling, the company said. Commenting on the development, Mr GV Prasad, CEO, Dr Reddys, said: The issuance of this letter reflects achievement of a key milestone for the company in its attempt to launch a speciality 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, Dr Reddys expects to launch Amlodipine Maleate on August 26, 2003, he said further.
Earlier, on June 17, 2002, Pfizer notified Dr Reddys that it had filed a suit in the Federal Court in New Jersey on one of the two Orange Book patents, the 909 patent. However, Pfizer did not file a suit on the second patent called 303 patent. Subsequently, DRL filed a motion for summary judgement and the motion is scheduled to be argued in mid-December 2002, the company said