FDA Approvals - Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by
Watson Announces Oxybutynin Topical Gel NDA Accepted for Filing by FDA for the Treatment of Overactive Bladder (PR Newswire via Yahoo! Finance)
Watson Pharmaceuticals, Inc. , a leading specialty pharmaceutical company, announced today that its New Drug Application for oxybutynin chloride topical gel , has been accepted for filing by the U.S.
The Medicines Company Receives FDA Review Letter for Angiomax Supplemental Filing (Business Wire via Yahoo! Finance)
PARSIPPANY, N.J.----The Medicines Company announced receipt of a not approvable letter from the U.S. Food and Drug Administration on a supplemental New Drug Application for an additional dosing regimen for Angiomax in the treatment of acute coronary syndromes initiated in the emergency department.
LDR Spine has received FDA clearance for a partial vertebral body replacement device, the (Medical Device Link)
Austin Business Journal reports. The ROI-T device has a shape that conforms to the anterior vertebral body. But it is thin and its end is tapered, so it can be implanted in a minimally invasive procedure. The company says more new product approvals should come by the end of the year.