Medical Letter on the CDC & FDA
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Generic Drugs
First tentative approval for generic, MetroGel, received
October 23rd, 2005
Fougera, a specialty manufacturer of dermatologic and ophthalmic pharmaceuticals, announced that it has received tentative U.S. Food & Drug Administration (FDA) approval to introduce the first generic version of Metronidazole Topical Gel USP 0.75%. The patent on the branded product by Galderma expires on June 6, 2006. MetroGel generated approximately $75 million in sales in 2004. It is indicated for the treatment of rosacea. MetroGel represents the eighth FDA approval and the third first-generic for Fougera thus far in 2005. "Our success in developing and marketing a consistent stream of topical products is gratifying. We continue...
Source: Medical Letter on the CDC & FDA (2005-10-23)
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