...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 XR topiramate as monotherapy treatment... ...in adults. The company expects to receive final approval when pediatric exclusivity for immediate-release Trokendi topiramate... ...seizures or with seizures associated with Lennox-Gastaut syndrome. The drug is an extended-release formulation of topiramate...
...Supernus said FDA asked the company to resubmit its proposed label for Trokendi XR topiramate to... ...PDUFA date was in 2Q16. The extended-release formulation of topiramate is approved to treat epilepsy. Topiramate... ...receptor antagonist and carbonic anhydrase inhibitor. Supernus Pharmaceuticals Inc. (NASDAQ:SUPN), Rockville, Md. Product: Trokendi XR topiramate...
...Supernus granted Endo’s Par Pharmaceutical company rights to sell the generic version of Trokendi XR topiramate... ...submitted an ANDA for approval of a generic version of Supernus’ extended release formulation of topiramate...