New User:

-or-
Username:
Password:
Forgot your password?

Stock Market & Financial Investment News

News Breaks
October 12, 2012
08:40 EDTIPXLImpax extended FDA review a marginal negative, says Wells Fargo
Wells Fargo views the FDA's extension of the review period for Impax's Rytary as marginally negative since the data was an expected near-term catalyst for shares. However, Wells notes the FDA did not request any new clinical trials and that the delay provides more time for Impax to resolve the warning letter is previously received. Wells keeps a Market Perform rating on Impax.
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