Archive for April, 2008

FDA confirms safety and efficacy of generic Wellbutrin

Teva LogoThe FDA has concluded that Teva Pharmaceutical’s bupropion XL 300 mg, a generic version of Wellbutrin XL, is a safe and effective treatment for patients suffering from depression. Questions about the safety and efficacy of Teva’s bupropion XL arose after the agency received 85 postmarketing reports of patients experiencing side effects after switching from GlaxoSmithKline’s Wellbutrin (bupropion HCl) to the generic version.

Mylan receives FDA nod for generic Plendil

Mylan Logo Mylan Pharmaceuticals has received final approval from the FDA for its ANDA for felodipine extended-release tablets as a treatment for hypertension. Felodipine is the generic version of AstraZeneca’s Plendil. Mylan aims to start shipping generic Plendil immediately.

InterMune to initiate further study on pirfenidone in IPF

InterMune LogoInterMune Inc. announced that it will initiate an open-label roll-over study to evaluate the long-term safety of pirfenidone in patients with idiopathic pulmonary fibrosis (IPF)who have completed one of the two concurrent Phase III CAPACITY trials of pirfenidone in IPF. Pirfenidone, which has been granted orphan drug designation in the both the U.S. and Europe, has depicted positive impact on lung function and disease progression in patients suffering from the fatal IPF disease.

Herbal Science International recalls 12 dietary supplements

Herbal Science International Inc is recalling twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers. FDA has long regarded dietary supplements containing ephedra as potential health hazards because this botanical contains ephedrine alkaloids. Recent studies have confirmed that ephedrine alkaloids raise blood pressure and cause stress to the circulatory system, effects that are linked to adverse health conditions such as heart attacks and strokes.

Eon Mini neurostimulator gets nod from FDA and European CE Mark

St. Jude Medical Inc. has received approvals from the US Food and Drug Administration (FDA) and European CE Mark for its Eon Mini, the world’s smallest, longest-lasting, rechargeable neurostimulator to treat chronic pain of the trunk or limbs and pain from failed back surgery. The Eon Mini neurostimulator is marginally larger than the circumference of a U.S. silver dollar, has a thin 10 mm profile and weighs 29 grams (approximately 1.0 oz.). Its small size allows for a smaller incision, which gives physicians increased flexibility in selecting the implant location and is intended to make the site less visible and more comfortable for patients.

Patent for virtual telemicroscope

Motic logoScientists at SUNY Downstate Medical Center in Brooklyn and Peking University in Beijing have received a U.S. patent for their virtual telemicroscope. This software may be used by offsite pathologists to diagnose diseases in patients located elsewhere. Chinese company Motic has used the patent to create a microscope that scans the slides at different magnifications and the compressed images produced thereafter are emailed to various required locations.