Teva’s migraine drug is expected to launch this year despite the delay in FDA approval
Teva Pharmaceutical’s fremanezumab for treating migraine is expected to launch later this year. Celltrion disclosed that U.S. drug regulators issued a Form 483 for its plant in Incheon, South Korea on tuesdsy. Eight manufacturing violations were observed by the drug regulators. Since January, Celltrion has been critical of the Incheon plant, when it sent a warning letter detailing how — among other things — there weren’t written procedures in place to prevent microbial contamination of drug products. In May Amgen and Novartis’ Aimovig (erenumab) received FDA approval for that indication. Fremanezumab will be second in the market and it seems that there is a three-month delay on FDA’s approval for fremanezumab.