Drugs

FDA OKs TE Code for Paclitaxel Suspension

Responding to an 8/30/2022 petition submitted by HBT Labs, FDA says it has determined that cancer drug paclitaxel particle bound particles for injectable suspension (albumin-bound) 100 mg/vial and Abraxane (paclitaxel protein bound particles for injectable suspension) are pharmaceutically equivalent and bioequivalent, and can be expected to have the same clinical effect and safety profile when administered under the conditions specified in their labeling. Thus, the agency says, it is granting part of the petition’s request and is approving an AB therapeutic equivalence (TE) code for paclitaxel protein bound particles for injectable suspension (albumin-bound) 100 mg/vial.

The petition had requested an AP TE code, but FDA says it determined that an AB code was appropriate.

The petition also claimed that a TE code would allow HBT to be exempt from, or otherwise get a refund of, any PDUFA annual program fees FDA may assess on the paclitaxel NDA for Fiscal Year 2023 and thereafter. The agency response says that while it agrees that paclitaxel qualifies for the pharmaceutically equivalent exception to annual PDUFA program fees, applicants must submit a written request for a return of program fees not later than 180 calendar days from the date the fee is due. “This is the case even if the applicant has submitted a citizen petition that may relate to a potential claim for a refund,” the FDA response says.

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