Schering-Plough announced that the FDA has approved Asmanex Twisthaler 110 mcg (mometasone furoate inhalation powder) for the maintenance treatment of asthma as a preventive therapy in patients 4 to 11 years of age. Asmanex is an inhaled corticosteroid (ICS). Asmanex 220 mcg was approved on March 31, 2005 by the FDA for maintenance treatment of asthma as preventive therapy in patients 12 years of age and older.
Watson Pharmaceuticals said it expects to initiate shipments of alendronate sodium in the 35 and 70 mg once weekly dosage strengths when Merck's Fosamax loses market exclusivity, which is anticipated to occur at the close of business on Feb. 6. Alendronate sodium is the generic version of Merck's Fosamax tablets, indicated for the treatment of osteoporosis in postmenopausal women. Alendronate sodium is also indicated to increase bone mass in men with osteoporosis. Under terms of a supply agreement, Merck will manufacture and supply the alendronate sodium tablets to Watson, which will market, sell and distribute the product in the US. Merck will receive a share of the profits from Watson's sales of the generic product in the US market. Further details on the agreement were not disclosed.