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Mylan Wins Its Amlodipine Case With Pfizer

PITTSBURGH, Mylan Laboratories Inc. (NYSE: MYL) today announced that the U.S. Court of Appeals for the Federal Circuit today granted its motion for a reversal of the district court judgment in its patent infringement litigation with Pfizer concerning amlodipine besylate. ......On February 22, 2007, the district court for the Western District of Pennsylvania had ruled in favor of Pfizer and Myla...

Mylan Announces Tentative FDA Approval for Its ANDA

Mylan Laboratories Inc. today announced that Mylan Pharmaceuticals Inc. has received tentative approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Paroxetine Hydrochloride Extended-release Tablets, 12.5 mg and 25 mg. ......Mylan's ANDA is eligible to receive final approval on June 29, 2007, concurrent with the expiration of the pediatric...

Mylan Announces Final FDA Approval for Fluoxetine Capsules

Mylan Laboratories Inc. (NYSE: MYL) announced that Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 40 mg. ......Fluoxetine Capsules are the generic version of Eli Lilly and Company's Prozac(R) Capsules. Fluoxetine Capsules had U.S. sales of approximat...
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