Mylan's generic Doryx ANDA receives final FDA approval

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), which is a tetracycline-class antimicrobial.  

Mylan CEO Heather Bresch commented: "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 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. 

Doxycycline Hyclate DR Tablets had U.S. sales of approximately $264.1 million for the 12 months ending Dec. 31, 2011, according to IMS Health.

Currently, Mylan has 173 ANDAs pending FDA approval representing $98.3 billion in annual sales, according to IMS Health. Forty-three of these pending ANDAs are potential first-to-file opportunities, representing $26.6 billion in annual brand sales, for the 12 months ending June 30, 2011, according to IMS Health.