Mylan (MYL) Gets FDA Approval for Generic Doryx
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Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Doxycycline Hyclate Delayed-release (DR) Tablets USP, 150 mg. This product is the generic version of Mayne Pharma's Doryx (marketed by Warner Chilcott (Nasdaq: WCRX)), which is a tetracycline-class antimicrobial.
Mylan has agreed that it will not launch its generic Doryx product until after a decision is issued in Warner Chilcott's patent infringement lawsuit against Mylan. This trial is underway in the U.S. District Court for the District of New Jersey (Newark) and a decision is currently expected in March.
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Mylan has agreed that it will not launch its generic Doryx product until after a decision is issued in Warner Chilcott's patent infringement lawsuit against Mylan. This trial is underway in the U.S. District Court for the District of New Jersey (Newark) and a decision is currently expected in March.
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