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.
Valencia, Calif.-based SetPoint Medical has hired Sagentia to develop a programming interface for a neuromodulation device designed to provide a lower-cost and lower-risk alternative to immunosuppressive drugs such as prednisone that treat chronic inflammatory diseases such as Crohn’s disease and rheumatoid arthritis.
The European Commission Dec. 5 granted AstraZeneca (AZ) European marketing permission for its Fluenz Tetra live attenuated intranasal influenza vaccine for patients age 2 to 18. The vaccine is sprayed into each nostril, where its weakened viral strains induce protective immunity.
Home » FDA Approves Eisai’s Fycompa to Treat Partial Epileptic Seizures
FDA Approves Eisai’s Fycompa to Treat Partial Epileptic Seizures
The FDA has approved Eisai’s Fycompa tablets to treat partial-onset seizures in epilepsy patients ages 12 and older. Partial seizures are the most common type of epileptic seizure and some patients do not get satisfactory control from current treatments, Russell Katz, director of CDER’s Division of Neurology Products, said Monday. “It is important to have a variety of treatment options available for patients with epilepsy.” Drug Industry Daily