Drugs

FDA Denies Insys’ Syndros Petition

FDA has denied a 11/8/17 Insys Therapeutics petition asking that it decline to approve any ANDA for generic dronabinol oral solution that cites Syndros as the reference-listed drug if it relies on a waiver in lieu of establishing in vivo bioequivalence to Syndros and to require that ANDA applicants for generic Syndros include fed and fasted state bioequivalence studies.

The agency denial letter says the company argued that fed and fasting bioequivalence studies are required due to the drug’s complexity and directions for use of the product with food. The company also said that a waiver is inappropriate because metabolite equivalence should be measured in addition to parent drug equivalence.

The agency says it disagrees with the company’s assertions about the need for bioequivalence tests and the lack of suitability of a waiver. FDA also noted that it would not decline to receive any ANDA relying upon a waiver because during its initial assessment of an ANDA, it does not evaluate the sufficiency of specific data or information submitted by the applicant to satisfy a requirement for approval such as bioequivalence.

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