Score one for Mylan, but they’ll still have to score twice. The generic drug maker announced today that the FDA has approved its sale of a copycat version of a medicine called Doryx for severe acne. Doryx is sold in the U.S. by Irish specialty drug maker Warner-Chilcott, which has been trying to delay generic competition for the drug. It’s sued Mylan for patent infringement in federal court; Mylan, which is waiting for a resolution before selling generic Doryx, says it expects a decision in March. Among Warner Chilcott’s other moves to delay competition: adding a second line, or “score,” across the top of Doryx tablets and arguing that generic rivals would also have to dual-score their proposed copies. Drug makers add these scores to help patients split pills. Warner Chilcott argued to the FDA that patients might have trouble dividing their tablets into thirds if they

wound up receiving a generic with only one score. In granting approval to Mylan, the FDA rejected Warner Chilcott’s argument. “There is very little chance” of a safety issue, the agency said, noting that Warner Chilcott sold both single- and dual-scored Doryx pills for a time after introducing the dual-scored pills, but didn’t add a warning to the labeling. The FDA asked Mylan to add a second score to its generic Doryx pills during its next manufacturing run, however. Mylan CEO Heather Bresch, in a statement , called Warner Chilcott’s effort “baseless” and said the company is “extremely pleased” with the FDA’s action. A Warner Chilcott investor relations official did not immediately return a call seeking comment. According to Mylan, the 150-milligram Doryx tablets had $264.1 million in 2011 sales. Image: iStockphoto

View original here: 
The Score on Scoring: Mylan 1, Warner Chilcott 0