New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
July 29, 2014
08:18 EDTIPXLImpax announces FDA performs inspection on Taiwan facility
Impax announced that the FDA performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at the company's Taiwan manufacturing facility from July 21 to July 26. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States. The FDA did not provide any status or classification to these observations and will wait until they have received and reviewed the company's response to provide this information. The Ccmpany has also not been informed by the FDA of the impact this Form 483 may have on RYTARY's October 9 review date under the Prescription Drug User Fee Act.
News For IPXL From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
February 2, 2016
07:36 EDTIPXLImpax receives tentative FDA approval for generic Vytorin ANDA
Impax Laboratories announced that Impax has received tentative approval from the U.S. FDA for its Abbreviated New Drug Application for the generic version of the ezetimibe and simvastatin containing tablets, in 10 mg / 10 mg, 10 mg / 20 mg, 10 mg / 40 mg and 10 mg / 80 mg strengths. "We are pleased to receive tentative approval from the FDA for our generic version of Vytorin tablets," said Fred Wilkinson, President and CEO. "We will continue to work with the FDA to gain final approval upon the expiration of the U.S. patents and associated pediatric exclusivity on April 25, 2017, and are currently planning to be among the first generic products to market."

Sign up for a free trial to see the rest of the stories you've been missing.
I agree to the theflyonthewall.com disclaimer & terms of use