When it comes to seizure treatment, timing is key. Now, armed with a nod for an easily-storable version of the status epilepticus drug fosphenytoin, Sedor Pharmaceuticals aims to get the potentially life-saving treatment into places where patients can be treated quickly.
Enforcement Report - Week of November 22, 2017
Mylan N.V. (NASDAQ, TASE: MYL), today announced the U.S. launch of Fosphenytoin Sodium Injection USP, 75 mg/mL, (50 mg PE*/mL), packaged in 100 mg PE*/2 mL, and 500 mg PE*/10 mL single-use vials, a generic version of Pfizer's Cerebyx® Injection. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, for the treatment of certain types of severe seizures. (1)