Drugs

AdventaPharma Wants Generic Ozempic Conditions

AdventaPharma is asking FDA not to approve any ANDA using Novo Nordisk’s Ozempic (semaglutide injection) as the reference-listed drug unless two conditions are met. The 8/26 petition says FDA should require that:

the generic drug/device combination product includes a pen injector that is functionally equivalent to the reference-listed drug; and
if the semaglutide active pharmaceutical ingredient (API) is produced via an intermediate such as, but not limited to, P29, derived through a fermentation route, the API should be classified as a hybrid API, not a purely synthetic one, with established adequate controls to reduce immunogenicity risk.

“Approving semaglutide ANDAs that rely on Ozempic as the reference-listed drug with non-equivalent devices and hybrid API jeopardizes patient safety and undermines the foundation of generic drug approval,” the petition says. “The effectiveness and safety of Ozempic depend significantly on the functional design and ease of use of its auto-injector. While equivalence is essential for the active substance, it alone cannot assure therapeutic equivalence for a drug/device combination. Functional differences in generic auto-injectors may introduce risks of dosing errors, reduced adherence, and compromised treatment outcomes.”

The petition says that failing to impose the requested conditions risks: dosing errors leading to hypoglycemia or ineffective treatment, erosion of trust in generic substitution, avoidable adverse events in vulnerable populations, and risk of immunogenicity.

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