Mylan Pharmaceuticals Inc. has received a final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for amlodipine besylate tablets.
Amlodipine besylate tablets are the generic version of Pfizer's Norvasc tablets, which had US sales of approximately $2.5 billion for the 12-month period, ended June 30, 2005, according to IMS Health.
The FDA has confirmed that Mylan was the first generic company to file on all strengths of Norvasc tablets and is therefore eligible for 180 days of market exclusivity. It has indicated that the exclusivity will begin to run from the earlier of the commercial launch of the Mylan product or a final court decision concerning the pending litigation between Pfizer and Mylan, informs a company release.
Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories, Inc., that develop, license, manufacture, market and distribute an extensive line of generic and proprietary products.