Drugs

Apotex India-made Ingredient Costs Biohaven NDA Approval

FDA has issued Biohaven Pharmaceutical Holding Co. a complete response letter on a 505(b)2 application seeking approval for Nurtec (riluzole) for treating amyotrophic lateral sclerosis (ALS). The letter raised concerns with the use of an active pharmaceutical ingredient (API) that was manufactured by Apotex Pharmachem India Private Ltd. between 2014 to 2016 and used in the drug product supplies for the bioequivalence study in 2017. FDA concerns with Apotex’s manufacturing recently led to the withdrawal of 31 drug products from the U.S. market (see earlier story).

In the letter, FDA stated that it provided recommendations to Apotex regarding the information that would be needed to qualify previous API batches manufactured at Apotex during the time period in question, Biohaven says. “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 (riluzole),” it says. “Biohaven has been subsequently informed by the manufacturer that they had an exemption from the FDA to supply riluzole to the U.S. market during that time period.“

Additionally, Biohaven says it has been in contact with FDA and Apotex to resolve the matter and Biohaven has already submitted additional information to the agency regarding this issue. It notes that the API for commercial supply of Nurtec is currently sourced from another supplier that does not have manufacturing issues.

Nurtec is a sublingually administered tablet. While riluzole is FDA-approved for ALS, existing formulations consist only of an oral tablet taken with water or an oral suspension.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome