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Category: Pediatric Exclusivity
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Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007. Mylan launched its generic Norvasc last week and, with the exception of Pfizer’s authorized generic, currently has the only generic…
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Pfizer v. Mylan Labs. et al., No. 02-1628 (W.D. Pa. 2007) For the third time, Pfizer’s patent on Norvasc has withstood a validity challenge from a generic rival. Following a week-long trial held last year, Judge Terrence F. McVerry of the U.S. District Court for the Western District of Pennsylvania ruled yesterday that Pfizer’s U.S.…
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A recent report published in the Journal of the American Medical Association found that the FDA’s Pediatric Exclusivity Provision (PEP) does not necessarily yield lucrative returns for innovator drug companies. The PEP authorizes the FDA to grant innovator drug companies a six-month extension of marketing exclusivity (beyond patent expiration) in exchange for conducting studies of…
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