Drugs

Reject Cipla NDA for Descovy Duplicate: Gilead

Gilead Sciences is petitioning FDA to rescind its decision to file a Cipla 505(b)(2) application for an apparent duplicate of Gilead’s Descovy (emtricitabine and tenofovir alafenamide) tablets. The petition also asks the agency to refuse to grant the Cipla product an A rating, reflecting a determination of therapeutic equivalence, should such a determination become relevant.

The petition argues that Cipla should have submitted an ANDA rather than a 505(b)(2) NDA because the only apparent difference between the Cipla product and Descovy relates to the amount of tenofovir alafenamide fumarate (TAF) active ingredient in both products. It says the ratio of fumaric acid to TAF is 1:1 in Cipla’s product and 0.5:1 in Descovy. “This difference does not cause Cipla’s product and Descovy to have different active ingredients” for several reasons, Gilead says.

“In the absence of any difference from Descovy that would preclude Cipla’s proposed product from being submitted as an ANDA,” the petition says, “Gilead requests that FDA rescind its decision to file Cipla’s 505(b)(2) application for an apparent duplicate of Descovy.”

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