Mylan Remains The Only Approved ANDA For All Strengths Of Amlodipine Besylate Tablets

Armen Hareyan's picture

Amlodipine Besylate Tablets

Mylan Laboratories Inc. announced that the U.S. District Court for the District of Columbia issued a decision denying all requests for preliminary injunction related to Amlodipine Besylate Tablets and supporting the U.S. Food and Drug Administration's position concerning Mylan's current status as the only approved ANDA for all strengths of this product.


In the decision, the District Court confirmed the position taken by the FDA that all of the unapproved amlodipine besylate ANDAs are currently blocked from approval by pediatric exclusivity.

Mylan received final FDA approval for all strengths of Amlodipine Besylate Tablets on October 4, 2005, and commercially launched all strengths on March 23, 2007, after the U.S. Court of Appeals for the Federal Circuit in Washington ruled that claims 1-3 of the '303 patent were invalid. Amlodipine Besylate Tablets are the generic version of Pfizer's Norvasc(R) Tablets, which had U.S. sales of approximately $2.7 billion for the 12-month period ending Dec. 31, 2006, according to IMS Health.

Mylan Laboratories Inc. is a leading pharmaceutical company with three principal subsidiaries, Mylan Pharmaceuticals Inc., Mylan Technologies Inc. and UDL Laboratories Inc., and a controlling interest in Matrix Laboratories Limited, India. Mylan develops, licenses, manufactures, markets and distributes an extensive line of generic and proprietary products.