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.

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.

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.

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.

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.

Alcon Inc. has received the FDA approval for Patanase, an antihistamine nasal spray that relieves symptoms of seasonal allergic rhinitis in patients aged 12 years and more. The company expects to make the steroid-free nasal spray, Patanase, available in the market in May.