Drugs

Clarus Wants FDA Testosterone-Ester Guidance

Clarus says FDA should establish clear written guidance on safety and efficacy standards required for oral testosterone-ester prodrugs as testosterone replacement therapy for adult men with a deficiency or absence of endogenous testosterone. A company petition also asks that the agency not approve any pending NDA for an oral testosterone-ester to treat male hypogonadism that fails to meet the approval standards listed in the petition.

The company says FDA should address the specific criteria that oral testosterone-ester prodrugs must meet regarding primary efficacy, secondary efficacy, dose titration, concordance, food effect, and characterization of post-collection conversion of specific testosterone-ester to testosterone in blood of men treated with oral testosterone-ester to assess clinical testosterone response.

FDA approved 3/27 Clarus’ Jatenzo, the first U.S. oral testosterone-ester product indicated for testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone.

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