Biohaven's Nurtec (riluzole) 505(b)2 Application for Amyotrophic Lateral Sclerosis Affected by Issues Related to Apotex Plant: Complete Response Letter (CRL) Received From FDA Related to Isolated Drug Substance Supply Used in Bioequivalence Study
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- Biohaven is already engaged with the FDA regarding next steps for a timely resolution of this matter and has submitted additional information to the Agency.
