Biohaven gets CRL on riluzole from FDA

USA-based Biohaven Pharmaceutical (NYSE: BHVN) revealed that it has received a Complete Response Letter (CRL) from the Food and Drug Administration for the 505(b)2 application seeking approval for Nurtec (riluzole) for amyotrophic lateral sclerosis (ALS), or Lou Gehrig's disease.

Biohaven’s shares closed down 1.54% at $44.10 on Friday following the announcement.

In the CRL, the FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous active pharmaceutical ingredient (API) batches manufactured at Apotex during the time period in question. Apotex did not provide Biohaven with notice of the FDA communication, either during the course of its bioequivalence trial or during the submission of its 505(b)2 application for Nurtec. Biohaven has been subsequently informed by the manufacturer that they had an exemption from the FDA to supply riluzole to the US market during that time period. Today, Biohaven has been in contact with the FDA's CMC group and Apotex to resolve the matter and Biohaven has already submitted additional information to the FDA regarding this issue.