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.