CANONSBURG (dpa-AFX) - Mylan Inc. (MYL) announced that its subsidiary Mylan Pharmaceuticals Inc. obtained final approval from the U.S. Food and Drug Administration, or FDA, for its Abbreviated New Drug Application for Doxycycline Hyclate Delayed-release Tablets USP, 150 mg. This product is the generic version of Mayne Pharma's Doryx, which is a tetracycline-class antimicrobial.
Mylan CEO Heather Bresch, said, 'We are gratified by FDA's approval of our generic Doryx 150 mg product. We have strongly believed from the very beginning that Warner Chilcott's citizen petition in reference to this product was baseless and are extremely pleased that FDA has now denied this petition.'
Mylan said it 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 the company. This trial is underway in the U.S. District Court for the District of New Jersey and a decision is currently expected in March.
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