Johnson & Johnson, of New Brunswick, N.J., said the FDA rejected its supplemental new drug application to use the anticoagulant Xarelto (rivaroxaban) to reduce the risk of heart attacks or strokes in patients with acute coronary syndrome. An application seeking to gain approval to use the drug in the same population to reduce the risk of stent thrombosis also was rejected in another complete response letter from the FDA. Xarelto, an oral anticoagulant, works by blocking a blood-clotting agent, and has been approved for several indications relating to reducing the risk of blood clots.

Mayne Pharma USA, of Greenville, N.C., has agreed to acquire the headache drugs Esgic (butalbital, acetaminophen, and caffeine) and Esgic Plus (butalbital, acetaminophen, and caffeine), as well as Lorcet (hydrocodone bitartrate and acetaminophen) and Lorcet Plus brands, for pain, and related assets from Forest Laboratories Inc., of New York, for $12 million. The deal consists of an up-front payment of $10 million, plus an earn-out of up to $2 million, payable quarterly calculated on a percentage of future net product sales. The acquisitions will allow Mayne to expand its product portfolio beyond generic products.

Shire plc, of Dublin, said the FDA has approved the production of Vpriv (velaglucerase alfa for injection) for Gaucher disease in Shire’s manufacturing facility in Lexington, Mass.