Cutting Edge Information

ANDA filings buy time for branded drugs

Published in Pharma Law Weekly, February 15th, 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...

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Source: Pharma Law Weekly (2005-02-15)

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