Drugs

Product-Specific Estring BE Guidance Needed: Pfizer

Pfizer is asking FDA to issue a product-specific bioequivalence (BE) guidance applicable to any ANDA for a generic version of its Estring (estradiol vaginal ring), and to require any ANDA applicant to establish bioequivalence for its generic Estring product based on the conditions set forth in such a guidance. The company’s petition says that Estring is a complex, controlled-release vaginal ring with unique features that are essential to its safety and efficacy profile.

“To ensure that a proposed generic version of Estring matches this safety and efficacy profile,” the company says, “Pfizer believes that the standards proposed in this Citizen Petition are critically important and should be considered by FDA in evaluating any ANDA that references Estring and purports to be therapeutically equivalent.”

The petition includes four requirements that Pfizer says should be included in a guidance document involving comparable in vitro release; an appropriately designed pharmacokinetic endpoints study assessing specific plasma bursts; an appropriately designed clinical endpoint study evaluating the product’s efficacy and safety; and demonstration that the ANDA product’s geometry, formulation, physical, and mechanical properties are equivalent to those of Estring.

The petition asks FDA to expedite its review “to ensure that appropriate BE standards are published as soon as possible,” given that there currently is no product-specific BE guidance for generic versions of Estring.

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