Amlodipine Update . . . .

April 10, 2007

Last week, we reported on several citizen petitions submitted to FDA by Mylan and Pfizer concerning the availability and applicability of 180-day exclusivity and pediatric exclusivity to amlodipine drug products.  FDA has also established a separate docket to solicit the views of interested parties on these issues as part of the Agency’s efforts to respond to the U.S. District Court for the District of Columbia’s order in Mylan Laboratories, Inc. v. Leavitt that FDA decide by Wednesday, April 11th whether it will approve any Abbreviated New Drug Applications (“ANDAs”) for generic amlodipine besylate besides Mylan’s ANDA.  In a new development, Zydus Pharmaceuticals (USA) Inc. has submitted a fourth citizen petition to FDA concerning amlodipine. 

The Zydus petition requests that FDA “file papers in opposition to plaintiff Mylan’s application for a [Temporary Restraining Order (‘TRO’)] in [Mylan Laboratories, Inc. v. Leavitt] and to seek a dissolution of the TRO . . . that lasts until April 13, 2007 at 5:00 pm.”  Zydus also requests that FDA “approve all complete amlodipine besylate ANDA[s] that are currently pending.”  In support of its requests, Zydus contends that:

Mylan through its petitions and TRO intends solely to prevent any other generic from entering the market during a period in which approved ANDA holders are rightfully permitted to enter the market. . . .  [Additionally,] by obtaining such an order, Mylan intends to extend the 180-day exclusivity period beyond that permitted statutorily . . . .  Zydus believes that Mylan has forfeited any 180-day exclusivity period that may have been awardable to it . . . .

Stay tuned for more updates on this evolving case.   



Earlier today, the U.S. District Court for the District of Columbia issued an order extending from April 11, 2007 to April 18, 2007 the date on which FDA must notify the court of the Agency’s decision with respect to the issues involved in Mylan Laboratories, Inc. v. Leavitt.  Further, the court changed the date until which FDA is enjoined from taking final agency action from April 13, 2007 to April 20, 2007.

Categories: Hatch-Waxman