Drugs

FDA Denies Pfizer Petition on Premarin Generics

FDA has denied an 8/2018 Pfizer petition urging FDA to tighten bioequivalence requirements for any ANDA submitter seeking approval for generic copies of its Premarin (conjugated estrogens) tablets. The petition sought to revise a 12/2014 draft guidance on methods for establishing active pharmaceutical ingredient sameness and bioequivalence for conjugated estrogens. Pfizer had earlier submitted comments on the “fundamentally flawed” guidance, but when FDA did not act on its recommendations, the company decided to submit the petition.

The petition asked FDA to require demonstrating sameness for conjugated estrogens using a publicly available liquid-chromatography/mass-spectrometry method that Pfizer developed. The company said the method was developed with input from FDA. “The Pfizer method permits a determination of sameness between a proposed generic product and Premarin based upon the mixture as a whole, and allows for a comparison across each of the different categories of components that make up the API,” the petition said.

In its denial letter, FDA said that its proposed method for assessing API sameness is not fundamentally flawed and it has been shown to be “accurate, specific, and reproducible for 60 steroidal compounds.” The agency noted that it will continue to consider the recommendations for developing generic drug products for naturally-sourced conjugated estrogens on a case-by-case basis.

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