FDA approves Mylan antimicrobial drug

Mylan to delay launch pending decision in patent-infringement suit filed by Warner Chilcott

PITTSBURGH — The Food and Drug Administration has approved an antimicrobial drug made by Mylan, the drug maker said Thursday.

The FDA approved Mylan's doxycycline hyalite delayed-release tablets in the 150-mg strength. The drug is a generic version of Warner Chilcott's Doryx.

Warner Chilcott launched a patent infringement suit against Mylan in the U.S. District Court for the District of New Jersey in response to the latter's filing for FDA approval of the drug. The court is expected to reach a decision in March, and Mylan said it agreed not to launch the drug until then, though it expected to be the first to launch a generic version.

Doryx had sales of about $264.1 million in 2011, according to IMS Health.

 


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