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.

Shire Pharmaceuticals Inc. has received FDA approval for its Vyvanse drug for the treatment of adult attention deficit hyperactivity disorder (ADHD). In the clinical trials, Vyvanse (lisdexamfetamine dimesylate) significantly improved symptoms of inattention, hyperactivity and impulsivity in ADHD patients within one week of treatment. The trials also depicted that the drug’s efficacy at 30, 50 and 70-mg doses was significantly greater than placebo.

The FDA has approved a second oral rotavirus vaccine, called Rotarix, which is in liquid form and is given in a two-dose series to infants of 6 to 24 weeks of age. The rotavirus infection results in vomiting and diarrhea in children. The new vaccine provides protection against the G1, G3, G4, and G9 strains, which cause rotavirus gastroenteritis. The vaccine is manufactured by GlaxoSmithKline Biologicals, of Rixensart, Belgium.

Spectrum Pharmaceuticals Inc. has received FDA approval for Levoleucovorin as a treatment for osteosarcoma. The drug has been approved for use after high-dose methotrexate therapy and to counteract the effects of impaired methotrexate elimination and an overdose of folic acid antagonists. The company intends to apply for FDA approval of Levoleucovorin in colon cancer and as an oral tablet by mid 2008.

Auriga Laboratories Inc has announced the launch of Extendryl® PEM and Extendryl® GCP. The two new products will be prescribed in the treatment of cough, cold and allergy symptoms. The company intends to strengthen the Extendryl product line and the product launch appears to be timed to coincide with the start of the Spring allergy season.

FDA has approved Adolor Corp. and GlaxoSmithKline PLC’s bowel drug Entereg to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery. Entereg is the first and only product that has demonstrated the ability to address this serious condition, which has negative consequences for patients, and imposes considerable expense on the healthcare system. Entereg will be available for short-term use in hospitals registered under the Entereg Access Support and Education Program. The program is designed to monitor use and prevent long-term outpatient use.

A new study in patients with early Parkinson’s disease demonstrates that Stalevo® (levodopa/carbidopa/entacapone) gives better symptom control and greater improvements in activities of daily living than levodopa/carbidopa, the most widely-used current therapy. The FIRST STEP study, designed to support regulatory filings in 2008 for the use of Stalevo in patients with early Parkinson’s disease (PD), indicated that the drug may provide greater benefits for patients over and above the levodopa/carbidopa therapy. Stalevo is currently used for certain Parkinson’s disease patients who experience end-of-dose motor (or movement) fluctuations, known as “wearing off.”

Baxa has been issued a warning letter by the FDA for failing to report two complaints in which the patients suffered serious injuries due to incorrect concentration administration of solutions caused by user error. The medical device reporting (MDR) requirements are very specific on the need for such events being reported.

A research conducted on a large patient population in the U.S. have shown that the use of the anti-inflammatory and painkiller ibuprofen is linked to lower risk of developing Alzheimer’s disease. According to the researchers, patients who took the drug for over 5 years were 40% less likely to develop the disease compared with patients who did not use that type of drug at all.

Sun Pharmaceutical Industries has received FDA approval for its Abbreviated New Drug Application (ANDA) for the generic version of Forest Laboratories’ Tessalon (benzonatate) capsule. Tessalon capsules are used in treating cough caused by common cold, pneumonia and other lung infections. According to Sun Pharma, the annual US sales of the brand and generic Tessalon are approximately $40 million.