Medical Letter on the CDC & FDA
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Drug Development
ANDA filings buy time for branded drugs
February 20th, 2005
The 180-day period of market exclusivity granted to the first generic drug company to file an abbreviated new drug application (ANDA) by the U.S. Food & Drug Administration (FDA) buys time for branded drugs soon to go off-patent, according to pharmaceutical intelligence firm Cutting Edge Information. The FDA recently accepted to review Spectrum Pharmaceuticals, Inc.'s Abbreviated New Drug Application (ANDA) with a Paragraph IV certification for sumatriptan succinate injection. This compound is a generic version of GlaxoSmithKline's Imitrex injections used to treated migraines. As the first to file an ANDA, Spectrum believes it is entitled to receive...
Source: Medical Letter on the CDC & FDA (2005-02-20)
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