A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
In a boost for Big Pharma, the European Medicines Agency (EMA) has raised the fee-reduction rate for non-small and medium-sized enterprises (SMEs) seeking assistance on non-pediatric-related protocol from 40 percent to 75 percent, in line with recommendations by the agency’s orphan medicinal products panel.
Home » Impax Can Launch Generic Renvela, Renagel in 2014 Following Genzyme Settlement
Impax Can Launch Generic Renvela, Renagel in 2014 Following Genzyme Settlement
Impax Laboratories can market generic versions of Genzyme’s kidney disease drugs Renvela and Renagel in 2014 under a settlement with the brand drugmaker. Genzyme has granted Impax a license to sell a generic version of Renvela (sevelamer carbonate) 800-mg tablets beginning March 16, 2014, Impax said Tuesday. Impax can also sell oral suspension versions of Renvela and Renagel (sevelamer hydrochloride) beginning Sept. 16, 2014. Drug Industry Daily