New products

August 10, 2012

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

RX CARE

New drugs

FDA has approved Belviq (lorcaserin hydrochloride), from Eisai and Arena Pharmaceuticals, as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes). FDA has recommended that the U.S. Drug Enforcement Administration (DEA) classify Belviq as a scheduled drug. After DEA determines the final designation, Eisai will announce U.S. availability. Arena will manufacture and supply the commercial product from its Swiss facility and Eisai will handle U.S. marketing and distribution. ( http://www.arenapharm.com/ / 858-453-7200)

Genentech's Perjeta (pertuzumab), a new anti-HER2 therapy to treat patients with HER2-positive late-stage (metastatic) breast cancer has received FDA approval. Perjeta is combined with trastuzumab, another anti-HER2 therapy, and docetaxel. It is intended for patients who have not received previous treatment for metastatic breast cancer with an anti-HER2 therapy or chemotherapy. HER2 is a protein involved in normal cell growth. It is found in increased amounts on some types of cancer cells (HER2-positive), including some breast cancers. Perjeta is administered intravenously and is believed to work by targeting a different part of the HER-protein than trastuzumab, resulting in further reduction in growth and survival of HER2-positive breast cancer cells. ( http://www/perjeta.com/ / 888-249-4918)

UCB has launched Neupro (rotigotine transdermal system) in the United States. Approved by FDA in April to treat the signs and symptoms of early and advanced idiopathic Parkinson's disease and moderate-to-severe primary Restless Legs Syndrome (RLS), Neupro, a once-daily patch that provides continuous delivery of the dopamine agonist rotigotine for 24 hours, is now available in U.S. retail pharmacies. Neupro should be stored in a refrigerator. There is no need for patients to transport these patches in special containers and they must not be stored in a freezer compartment. ( http://www.neupro.com/)

New formulation

Lupin Pharmaceuticals has received FDA approval for Suprax (Cefixime) 400-mg antibiotic capsules, which is a new dosage. The approval will expand Lupin's range of Suprax dosage forms available to treat the approved indications in appropriate patients. Product is available in 100 mg/5mL and 200 mg/5mL suspension, as well as 400-mg tablets. Lupin expects to commence shipping the product in the near future. ( http://www.lupinpharmaceuticals.com/ / 866-587-4617)