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Biotech / Medical : Mylan Labs
MYL 15.860.0%Nov 19 4:00 PM EST

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To: Neil H who wrote (376)3/24/2004 8:12:35 AM
From: Neil H  Read Replies (1) of 384
 
Mylan Receives FDA Approval and 180 Day Exclusivity for Nitrofurantoin
Wednesday March 24, 6:30 am ET

PITTSBURGH--(BUSINESS WIRE)--March 24, 2004--Mylan Laboratories Inc. (NYSE: MYL - News) is pleased to announce that the U.S. Food and Drug Administration has granted final approval for Mylan Pharmaceuticals' Abbreviated New Drug Application for nitrofurantoin monohydrate/macrocrystals capsules, 100 mg. Nitrofurantoin is the generic version of Procter & Gamble's Macrobid®.
Mylan was the first company to file a paragraph IV certification for nitrofurantoin, and as such is entitled to 180 days of marketing exclusivity.

Mylan intends to ship the product immediately.
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