Archive for August, 2009

ZENPEP approved by FDA for EPI

EurandEurand NV has received approval from the FDA for its New Drug Application (NDA) for ZENPEP (pancrelipase) Delayed-Release Capsules for the treatment of exocrine pancreatic insufficiency (EPI) in patients with cystic fibrosis (CF) or other conditions. ZENPEP is the only FDA-approved pancreatic enzyme product (PEP) that has been evaluated in clinical studies in adults and children aged one to 12 years. The drug will be available in four dosage strengths to meet the varied needs of infants, toddlers, adolescents and adults with EPI.

FDA approves MS drug Extavia

NovartisNovartis has received the FDA approval for its multiple sclerosis (MS) medicine Extavia. The drug has been approved for the treatment of relapsing forms of MS to reduce the frequency of clinical exacerbations. The therapy is also indicated for patients who have experienced a first clinical episode of MS and have features consistent with the disease as shown by magnetic resonance imaging.

Aurobindo Pharma receive tentative approval for generic Alzheimer`s drug

AurobindoAurobindo Pharma Ltd has received tentative nod from the US Food and Drug Administration (FDA) for 5 mg and 10 mg Donepezil Hydrochloride tablets. Donepezil Hydrochloride Tablets 5 mg and 10 mg is generic equivalent of Aricept tablets 5 mg and 10 mg of Eisai Medical Research and are indicated for the treatment of mild, moderate and severe demetia of Alzheimer’s type and fall under the central nervous system (CNS) therapeutic segment. The product had a market size of approximately $1.90 billion for the twelve month ending Dec 2008.

Study links stress to asthma

uscA new study conducted by a team led by Rob McConnell, professor at the University of Southern California (USC), indicated that children of stressed parents are more likely to develop asthma triggered by air pollution. Researchers found that stress and low parental education were also linked with larger effects of exposure to tobacco smoke during pregnancy.