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The US Food and Drug Administration’s review of Biohaven Pharmaceutical’s Nurtec, a treatment for amyotrophic lateral sclerosis, has been delayed because of problems with the active pharmaceutical ingredient, riluzole,supplied between 2014 and 2016 by Apotex Pharmachem India. Biohaven learned of the FDA’s concerns in a recent letter. It says Apotex did not communicate the concerns, contained in an earlier warning letter, during a bioequivalence trial and the submission of a new drug application. Biohaven is sourcing riluzole for commercial production from another supplier.
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