Drugs

Alcon Wants Durezol Bioequivalence Requirements

Alcon has petitioned FDA to change the bioequivalence testing requirements for any ANDA that cites its Durezol (difluprednate ophthalmic emulsion, 0.05%) as the reference-listed drug and also revise the product-specific bioequivalence draft guidance for difluprednate ophthalmic emulsion. “Petitioners believe that only in vivo pharmacokinetic testing or comparative clinical endpoint testing, and not in vitro testing, is sufficient to accurately, sensitively, and reproducibly measure bioequivalence of difluprednate ophthalmic emulsions,” the petition says.

According to Alcon, a January draft guidance on difluprednate said that an ANDA applicant could establish bioequivalence either through in vitro testing or an in vivo pharmacokinetic study in aqueous humor. The company wants the agency to require in vivo testing and drop the in vitro option.

If FDA denies the requests and retains the in vitro option, Alcon says, it should require additional in vitro testing as recommended in the petition to increase the likelihood that any meaningful differences between the in vivo bioavailability of generic difluprednant ophthalmic emulsion products and Durezol are detected.

A final guidance should be issued promptly, the petition says, with content that is consistent with the petition.

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