New Products for Pharmacists: Rx, OTC, and generics (May 2011)


A survey of new Rx, new generic, and new OTC products

Key Points


New drugs

FDA has approved Benlysta (belimumab for injection) from Human Genome Sciences and GlaxoSmithKline for treatment of systemic lupus erythematosus in patients receiving standard therapy, including corticosteroids, antimalarials, immunosuppressives, and nonsteroidal anti-inflammatory drugs. This is the first new therapy developed specifically for lupus and approved by FDA since 1955. ( or

Forest Laboratories' Daliresp (roflumilast) 500 μg tablets has been approved by FDA to reduce the risk of exacerbations in patients with severe chronic obstructive pulmonary disease associated with chronic bronchitis and a history of exacerbations. ( / 800-678-1605 ext. 66297)

Takeda's Edarbi (azilsartan medoxomil tablets) in 40-mg and 80-mg dosage strengths has been approved by FDA for treatment of hypertension in adults. ( / 877-825-3327)

Fortesta (testosterone gel) from Endo Pharmaceuticals is available for treating hypogonadism, also referred to as low testosterone, in men ≥18 years. Each actuation of the pump canister delivers 10 mg of testosterone in a clear, odorless gel. Fortesta is a C-III controlled substance. ( / 800-462-3636)

Allergan's Lastacaft (alcaftadine ophthalmic solution, 0.25% concentration), an H1 histamine receptor antagonist, prevents itching associated with allergic conjunctivitis. (

Akrimax Pharmaceuticals' NitroMist (nitroglycerin lingual spray) is available for acute relief or acute prophylaxis of angina pectoris due to coronary artery disease. Each 8.5-g aerosol containing 230 metered sprays delivers 400 μg of nitroglycerin on or under the tongue. (

FDA has approved GlaxoSmithKline's Promacta (eltrombopag tablets) to treat chronic immune (idiopathic) thrombocytopenic purpura in patients with insufficient response to corticosteroids, immunoglobulins, or splenectomy. (

Meda's Xerese (5% acyclovir/ 1% hydrocortisone cream) is available for treatment of recurrent herpes simplex labialis (cold sores). (

New generics

Qualitest and Endo announced that FDA has approved Emoquette (0.15 mg desogestrel/30 μg ethinyl estradiol tablets, generic for Ortho-McNeil's Ortho-Cept) for pregnancy prevention by women choosing oral contraceptives. (

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