New products: Rx, generics, OTC (July 2008)

Rx

NEW DOSAGE

The FDA has approved a new once-a-month dose of Actonel (risedronate sodium) tablets at 150 mg. The medication for the treatment and prevention of postmenopausal osteoporosis is approved to reduce the risk of fractures in postmenopausal women with osteoporosis. Actonel ( http://www.actonel.com/) is co-promoted by the Alliance for Better Bone Health, an alliance between Procter & Gamble Pharmaceuticals and sanofi-aventis.

NEW INDICATION

NEW GENERICS

Lupin Pharmaceuticals is offering ramipril in 1.25-, 2.5-, 5-, and 10-mg capsules. Ramipril is an AB-rated equivalent of King Pharmaceutical's Altace and is indicated for the treatment of hypertension. In June a federal court denied King's application for a restraining order against India-based Lupin ( http://www.lupinpharmaceuticals.com/).

Boca Pharmacal, http://www.bocapharmacal.com/, received approval for carbinoxamine maleate 4-mg tablet, the generic version of Pamlab's Palgic ( http://www.palgic.com/). The drug is indicated to treat seasonal and perennial allergic rhinitis; vasomotor rhinitis; allergic conjunctivitis due to inhalant allergens and food; mild, uncomplicated allergic skin manifestations of urticaria and angioedema; dermatographism; as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after acute manifestations have been controlled; and amelioration of the severity of allergic reactions to blood or plasma.