Mylan announced that it has received final FDA approval for its Abbreviated New Drug Application (ANDA) for Doxycycline hyclate delayed-release tablets USP, 150mg. This product will be the first generic version of Doryx (Warner Chilcott). 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. A decision is currently expected in March 2012.
Doxycycline hyclate is a tetracycline antibiotic indicated for the treatment of tetracycline-susceptible infections including respiratory, genitourinary, rickettsial, trachoma, as well as postexposure prophylaxis and treatment of anthrax.
For more information, call (800) RX-MYLAN or visit www.mylan.com.