Watson gets FDA application approval

Published: 09:08:32 PM, Thu 03 January 2013 UTC

PARSIPPANY, N.J. (AP) — Watson Pharmaceuticals Inc. said Thursday that a subsidiary has received regulatory approval for a generic drug designed for the treatment of heavy menstrual bleeding.

The company said that it intends to begin shipping the product immediately.

Watson said the tranexamic acid tablets are the generic equivalent to Ferring Pharmaceuticals' drug Lysteda. Ferring has filed patent infringement lawsuits against Watson, but the litigation is still pending.

Watson cited IMS Health data showing that Lysteda had U.S. sales of roughly $25 million in the 12 months that ended Nov. 30.

Watson, based in Parsippany, N.J., is the world's third-largest generics prescription drug manufacturer with more than 750 products marketed globally.

Shares gained $1.71, or 2 percent, to $85.92. Its stock is near the high end of its 52-week trading range of $55 to $91.47.

Tags: food and drug administration, ims health, watson pharmaceuticals inc., ferring pharmaceuticals, watson, health, prescription drug, thursday, n.j., 52-week trading range, percent, parsippany, generic drug, pharmaceutical industry, high end, company, treatment, marketing, shares, pharmacology, product, subsidiary, regulatory approval, u.s. sales, nov., litigation, pharmaceuticals policy, heavy menstrual bleeding, third-largest generics prescription, patent infringement lawsuits, tranexamic acid tablets, ims health data, generic equivalent, fda application, drug lysteda, drug manufacturer