Drugs

Imvexxy Bioquivalence Guidance Sought

TherapeuticsMD is asking FDA not to receive or approve any ANDA that references Imvexxy (estradiol vaginal inserts) unless the ANDA sponsor provides data consistent with the bioequivalence requirements suggested in the TherapeuticsMD petition. The company also asks the agency to issue a product-specific bioequivalence guidance for Imvexxy. It notes that product-specific guidances already have been issued for four other estradiol products.

Specifically, TherapeuticsMD says any ANDAs should demonstrate for each strength that it is Q1/Q2 same and Q3 similar to Invexxy by submitting data from these studies: a bioequiovalence study with pharmacokinetic endpoints; low surfactant dissolution testing; and a bioequivalence study with clinical endpoints. The petition also seeks specific elements in the bioequivalence study with clinical endpoints.

“If the formulation of a proposed drug product referencing Imvexxy is not Q1/Q2 and Q3 to Imvexxy, then bioequivalence cannot be established through existing bioequivalence test methods, and FDA should refuse to receive an ANDA for the drug product,” the company says.

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