Archive for September, 2008

Teva introduces Nicardipine HCl Injection in US

Teva Pharmaceutical Industries Ltd. has introduced its  Nicardipine Hydrochloride Injection, 2.5 mg/mL, in the United States of America. The injection is the first alternative to EKR Therapeutics’ treatment for high blood pressure, Cardene® I.V. According to IMS sales data, this product had annual sales of approximately $181 million in the United States from July 2007 to June 2008. As part of an agreement that Teva and Exela PharmSci, Inc. (a Reston, Virginia based company developing pharmaceuticals), entered into, Teva is licensed to manufacture and distribute the  Nicardipine HCl Injection.

Galvus treats Type 2 Diabetes in a better way

Data obtained from a new study GALIANT shows Galvus® (vildagliptin), an oral treatment for type 2 diabetes, is better tolerated and as effective as commonly prescribed anti-diabetic oral medicines, called thiazolidinediones (TZDs), when added to metformin. Galvus also eliminates a common side effect of other type 2 diabetes medicines – weight gain, by providing for control of body weight . Other data presented also demonstrated the favorable cardiovascular safety profile of Galvus and confirmed its tolerability in patients with mild-to-moderate renal impairment. A lower overall incidence of adverse cardiovascular events was recorded.

EMEA grants marketing authorization to INTELENCE

The European Medicines Agency has granted marketing authorization for the anti-HIV medication INTELENCE™ (etravirine), the first next generation non-nucleoside reverse transcriptase inhibitor (NNRTI) to show efficacy in patients with NNRTI-resistant HIV. Also known as TMC125, Intelence was developed by Tibotec Pharmaceuticals, Ltd. Janssen-Cilag International NV will hold the marketing authorization. It has the potential to suppress the virus to undetectable levels. Intelence, along with a boosted protease inhibitor and other antiretroviral medicinal products, is indicated for the treatment of HIV type 1 infection in adult patients with experience of antiretroviral treatment. The recommended oral dose of Intelence tablets is 200 mg (two 100mg tablets) twice daily following a meal.

FDA to evaluate Vytorin’s link with cancer

The FDA is reviewing the safety of Vytorin, which combines the cholesterol-lowering drugs Zocor and Zetia, after a clinical trial SEAS revealed that 4.1% of patients taking the drug died of some form of cancer. Although the impact is small, the FDA has alarmed doctors and patients about it. Meanwhile it has asked the manufacturers for further data. However, the FDA and the American Heart Association have said that the patients should not stop taking Vytorin or any other cholesterol drug as that may add to the risk of having a heart attack.