May 31, 2007
Internal Medicine World Report, September 2006, Volume 0, Issue 0

NEW DRUG/TEST APPROVALS

New Type 2 Diabetes Combo Pill Pioglitazone HCl plus glimepiride combination tablet (Duetact; Takeda). Indication: treatment for type 2 diabetes. Recommended dosage: the once- daily tablet will be available in 2 common doses of pioglitazone and glimepiride ? 30 mg/2 mg and 30 mg/ 4 mg. Adverse events: upper respiratory infection, weight gain, edema, hypoglycemia, headache. www.tpna.com

First Treatment for Hunter's Syndrome Idursulfase IV injection (Elaprase; Shire Human Genetic Therapies). Indication: Hunter's syndrome (mucopolysaccharidosis II). Recommended dosage: 0.5 mg/kg of body weight administered once weekly. Adverse events: headache, fever, cutaneous reactions, hypertension. www.shire.com

Gel for Seborrheic Dermatitis Topical ketoconazole (Xolegel; Barrier Therapeutics). Indication: seborrheic dermatitis in immunocompetent adults and children aged ≥ 12 years. Recommended dosage: once daily. Adverse events: application-site burning; headache. www.barriertherapeutic.com

New Flu Vaccine The FDA has approved this year's seasonal influenza (flu) vaccines that include the new virus strains expected to cause flu in the Northern Hemisphere in 2006-2007. The new formulation is identical to that recommended by the WHO and includes 1 strain from last year's vaccine along with 2 new strains. www.fda.gov

Automated Testing for HBsAg Two automated blood screening tests for hepatitis B ? the Abbott Prism hepatitis B surface antigen (HBsAg) and Prism HBsAg confirmatory tests? have been approved for use by laboratory technicians to screen donated blood for HBsAg. www.abbott.com

Generics ? Alprazolam extended-release (Barr), a generic version of Xanax XR (Pfizer). Indications: treatment for panic disorder, with or without agoraphobia. www.barrlabs.com

? Simvastatin (Ivax/Ranbaxy), the first generic version of Zocor (Merck). Indications: primary and secondary prevention of coronary events. www.fda.gov

? Venlafaxine (Teva), a generic version of Effexor (Wyeth-Ayerst). Indication: treatment for major depressive disorder. www.tevapharm.com

? Meloxicam, a generic version of Mobic (Boehringer Ingelheim). Indication: treatment for osteoarthritis. www.fda.gov/cder/consumerinfo/generic_equivalence.htm

? Finasteride (Teva), a generic version of Proscar (Merck). Indication: for men with benign prostatic hypertrophy; improves symptoms by reducing the size of the prostate. www.fda.gov

? Lamotrigine (Teva), a generic version of Lamictal (GlaxoSmithKline). Indication: treatment for patients with seizures because of epilepsy. www.fda.gov

NEW INDICATIONS

? Clopidogrel (Plavix; Sanofi-Aventis/ Bristol-Myers Squibb) for reducing the rate of death from any cause and the rate of the combined end point of reinfarction, stroke, or death in patients with acute ST-segment elevation myocardial infarction. www.plavix.com

? Adalimumab (Humira; Abbott) for reducing the signs and symptoms of active ankylosing spondylitis. www.rxabbott.com

? Levetiracetam (Keppra; UCB) injection for use as adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy. www.keppra.com

? Infliximab (Remicade; Centocor) to inhibit the progression of structural damage and improve physical functioning in patients with psoriatic arthritis. www.centocor.com

? Risendronate (Actonel; Procter & Gamble) to increase bone mass in men with osteoporosis. www.actonel.com

OTHER

Test to Distinguish Hoaxes from Bioterror Agents

The FDA is developing a quick, cost-effective way to screen for and identify bioterror agents and substances used in hoax incidences. The testing method uses mass spectrometry to identify and quantify compounds based on the structure and chemical properties of their molecules. The process is quick and has a very high degree of accuracy. www.fda.gov

Plan B Approved, with Restrictions On August 24, 2006, the FDA announced its approval of Plan B as an OTC option for emergency contraception?with restrictions. Often referred to as the "morning after pill," it will only be sold to women aged ≥18 years with proof of identification. Plan B will remain available by prescription only for women aged ≤17 years. Duramed, a subsidiary of Barr Pharmaceuticals, will make Plan Bavailable with a rigorous labeling, packaging, education, distribution, and monitoring program called CARE (Convenient Access, Responsible Education). The company hopes to bring the drug, which will only be available in pharmacies, to market by the end of this year. www.fda.gov

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