« FDA Licenses for Marketing New Therapy for Rare Genetic Disease | Main | Cardinal Health, US FDA amend infusion pump consent decree (PharmaBiz) »

FDA Approvals - Wockhardt gets US FDA nod to market Sumatriptan injections in


Wockhardt gets US FDA nod to market Sumatriptan injections in US for migraine (PharmaBiz)
Pharmaceutical and biotechnology major, Wockhardt will soon be launching Sumatriptan injections in the United States.

FDA Clears New Immune Response Claim For The CryoValve(R) SG Pulmonary Human Heart Valve (Medical News Today)
CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue processing company, announced that the U.S. Food and Drug Administration (FDA) has cleared a new claim for the CryoValve(R) SG pulmonary human heart valve. The new labeling claim relates to reducing a component of the immune response in recipients of the CryoValve SG.

GTx Announces Toremifene 80 mg NDA Accepted for Review by FDA (Centre Daily Times)
GTx, Inc. (Nasdaq: GTXI) announced today that the United States Food and Drug Administration has accepted for filing and review the New Drug Application (NDA) for toremifene 80 mg, an oral selective estrogen receptor modulator, which GTx seeks to market for the prevention of bone fractures in men with prostate cancer on androgen deprivation therapy (ADT).
 

©2006 FDA-News.com. All rights reserved.