Mylan Doxycycline Hyclate tablets win FDA ANDA approval
Mylan Pharmaceuticals has received Abbreviated New Drug Application (ANDA) acceptance from the US Food and Drug Administration (FDA) for its Doxycycline Hyclate Delayed-release (DR) tablets USP, 150 mg.
Doxycycline Hyclate DR tablets are the generic version of the company's Doryx, which is marketed by Warner Chilcott.
Mylan CEO Heather Bresch said they are pleased by FDA's approval of its generic Doryx 150 mg product.
The company has agreed that it will not introduce its generic Doryx product until after a decision is issued in Warner Chilcott's patent infringement lawsuit against Mylan.
The decision from the ongoing trial in the US District Court for the District of New Jersey is anticipated in March 2012.
According to IMS Health, Doxycycline Hyclate DR tablets have gained US sales of around $264.1m for the 12 months ending 31 December 2011.
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