Archive for July, 2009

Amag receives FDA approval for its iron deficiency drug

FerahemeAmag Pharmaceuticals has received clearance from the FDA to sell its iron deficiency drug in the US market. The intravenous drug, feromoxytol, will be marketed under the brand name Feraheme for adult patients suffering from anemia with chronic kidney disease. The company expects the drug tobe available for commercial use during the second half of July.

FDA approves painkiller Onsolis

BioDelivery Sciences International Inc has received approval from the FDA to market Onsolis to treat breakthrough pain in certain cancer patients. The drug is expected to be available in the fourth quarter of 2009 and will be commercialized in the US by Meda Pharmaceuticals. Onsolis delivers the potent opioid fentanyl via a film that sticks to the inside of a patient’s cheek.

HCTZ tablet for hypertension approved

Glenmark Generics Inc and partner InvaGen has got the Abbreviated New Drug Application (ANDA) approval from the FDA for Fosinopril Sodium and Hydrochlorothiazide tablet to be used for the treatment of hypertension. Fosinopril Sodium and Hydrochlorothiazide(HCTZ) tablets are available in both 10mg/12.5mg and 20mg/12.5mg strengths. While Glenmark would exclusively market and distribute the product in the US, InvaGen would manufacture and supply the drug.

FDA asks asthma drug makers to add precaution on labels

The FDA has asked the makers of Singulair, Accolate, Zyflo and Zyflo CR drugs to include the precaution regarding the reported changes in behavior and mood on their label. All these drugs are used to treat asthma and are leukotriene inhibitors, which affect the leukotriene pathway involved in the body’s response to inflammatory stimuli.

Parkinson’s May Improve Through Brain Device

A new study published in The Journal of the American Medical Association shows that deep brain stimulation may show better improvements in disability and quality of life, as compared to other state-of-the-art treatments for patients with advanced Parkinson’s disease. However, there were also more serious side effects in patients who got deep brain stimulation. Deep brain stimulation requires the surgical implantation of electrodes and a device in the brain in order to electrically stimulate certain brain regions.