...on the frequency and severity of headaches. Standard of care for both indications includes generic topiramate... ...that are difficult to tolerate in a chronic setting, such as weight gain or sedation. Topiramate... ...and III trials were allowed to remain on stable background therapy with preventive agents like topiramate...
...FDA granted final approval to an sNDA from Supernus for Trokendi XRtopiramate as monotherapy treatment of... ...Trokendi topiramate from Johnson & Johnson (NYSE:JNJ, New Brunswick, N.J.) expires on March 28, 2017. Trokendi XR... ...data on safety and efficacy. Supernus Pharmaceuticals Inc. (NASDAQ:SUPN), Rockville, Md. Product: Trokendi XRtopiramate (formerly SPN-538...
...Supernus said FDA asked the company to resubmit its proposed label for Trokendi XRtopiramate to prevent... ...PDUFA date was in 2Q16. The extended-release formulation of topiramate is approved to treat epilepsy. Topiramate... ...antagonist and carbonic anhydrase inhibitor. Supernus Pharmaceuticals Inc. (NASDAQ:SUPN), Rockville, Md. Product: Trokendi XRtopiramate (formerly SPN-538...
...Supernus granted Endo’s Par Pharmaceutical company rights to sell the generic version of Trokendi XRtopiramate starting... ...submitted an ANDA for approval of a generic version of Supernus’ extended release formulation of topiramate...