Helix Exams

Date Submitted: 12/10/07
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New seizure medicine may be approved soon



Added by Kelsea

Description: Pfizer Inc announced in late October, 2003, that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA), seeking approval for a new seizure medicine called pregabalin (pree-gab-uh-lin). Pregabalin has been tested as an add-on (adjunctive) treatment for people with partial seizures that are not well controlled by other medications. An NDA is the final step before the FDA authorizes a medication to be sold in the United States. This application gives the FDA complete information on the history of the medicine, including details about clinical trials that have tested the medicine in patients. The time between filing of an NDA and approval of a new medicine for sale averages at least 1 year.

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