Magazine article Drug Topics

New Products

Magazine article Drug Topics

New Products

Article excerpt

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 (www.actonel.com) is co-promoted by the Alliance for Better Bone Health, an alliance between Procter & Gamble Pharmaceuticals and sanofi-aventis.

Taclonex Scalp (calcipotriene 0.005% and betamethasone dipropionate 0.064%) topical suspension from Warner Chilcott and LEO Pharma has been approved by the FDA. Taclonex is indicated for the treatment of moderate to severe psoriasis vulgaris of the scalp in adults. The drug is called Xamiol outside the United States. More information can be found at: www.taclonex.com.

NEW INDICATION

The indication for Reclast (zoledronic acid) Injection has been broadened to include the prevention of new clinical fractures in patients who have recently had a low-trauma hip fracture. The drug from Novartis (www.reclast.com) is administered as a once-yearly 15-minute intravenous infusion.

NEW GENERICS

Teva Pharmaceuticals (www.tevausa.com) and Mylan (www.mylan.com) are each introducing ropinirole hydrochloride tablets in 0.25-, 0.5-, 1-, 2-, 3-, 4-, and 5mg strengths. Ropinirole HCl is AB rated and bioequivalent to Requip tablets from GlaxoSmithKline (www.gsk.com) and is indicated for the treatment of moderate to severe primary restless lees syndrome.

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 (www. lupinpharmaceuticals.com).

Boca Pharmacal, www.bocapharmacal.com, received approval for carbinoxamme maleate 4-mg tablet, the generic version of Pamlab's Palgic (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.

Teva, Mylan, and Roxane Laboratories (www. …

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