New Delhi, Oct. 22: Dr. Reddy’s Laboratories today announced that the US Food and Drug Administration (USFDA) has determined the new drug application (NDA) submitted by the company for Amlodipine Maleate as “approvable”.
The Hyderabad-based drug company, which is listed on the US bourses, said the final approval of the NDA is contingent on the successful completion of ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labelling. It is also contingent on a successful outcome in the patent term extension litigation with Pfizer, the company said.
“We are particularly pleased that our very first NDA was determined ‘approvable’ by the FDA within 10 months. Depending upon a successful outcome in the patent term extension litigation with Pfizer, we expect to launch Amlodipine Maleate on August 26, 2003,” CEO G. V. Prasad said.
“The issuance of the approval letter reflects the achievement of a key milestone for Dr. Reddy’s in its attempt to launch a speciality product in the US market,” Prasad said.
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 this year, 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. It 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.
Amlodipine Besylate is the generic version of Pfizer’s Norvasc and is indicated for the treatment of hypertension and angina. Amlodipine Mesylate has the same active component but has a different salt, an innovation by Dr Reddy’s Laboratories.