07/24/2017 - 1:26pm

At a public meeting on July 18, Food and Drug Administration commissioner Scott Gottlieb said that by the end of the year, the agency would develop an internal strategy for dealing with abbreviated new drug applications, as well as a guidance on the best submission practices.

07/24/2017 - 12:57pm

he company said that Renflexis would be launched with a wholesaler acquisition cost of $753.39, which it said is a 35% discount to Remicade’s current list price. 

07/21/2017 - 1:37pm

The drug has met all of the Food and Drug Administration's requirements but is facing an automatic stay as the result of litigation with Sanofi, who has claimed patent infringement on it Lantus insulin. 

07/21/2017 - 1:13pm
07/19/2017 - 12:50pm

Perrigo said that it anticipates launching the generic ear drops within 90 days.

07/18/2017 - 2:14pm

The combined products have a market size of $315.9 million for the 12 months ended May 2017 according to QuintilesIMS data.

07/18/2017 - 12:15pm
The organization has named Kristin Murphy its director of federal affairs, promoting Michael Brzica to the role of VP federal government affairs.
 
07/17/2017 - 2:59pm

The drug had annual U.S. sales of $88 million for the 12 months ended May 2017, according to QuintilesIMS data.

07/17/2017 - 2:34pm

The drug had U.S. sales of approximately $1.8 billion for the 12 months ended May 2017, according to QuintilesIMS data.