Drugs

FDA Denies Belbuca Petition

FDA has denied a 10/21/21 petition submitted by BioDelivery Sciences International, Raleigh, NC, asking the agency to take certain actions on applications for follow-on buprenorphine buccal film products. Specifically, the petition asked that the agency:

require any applicant for a low or high pH buprenorphine buccal film product citing BioDelivery’s Belbuca (buprenorphine buccal film) as the reference-listed drug to include in the application adequate safety data, including data from the relevant patient population, from a comparative clinical investigation using relevant safety endpoints;
refuse to approve an ANDA and require submission of a 505(b)(2) NDA to the extent that FDA determines that other than “limited confirmatory testing” evidence is needed to address pH safety concerns; and
revise the agency’s product-specific bioequivalence guidance for generic Belbuca and issue guidance for the approval of oral mucoadhesive films that address the pH concerns discussed in the petition.

The FDA 3/18 denial letter says the BioDelivery petition (1) did not provide any scientific support for its assertion that follow-on products with a different pH range than Belbuca’s will result in local irritation or changes in bioavailability due to local irritation; (2) did not demonstrate that studies of temperature and pH of liquids are necessary; and (3) did not demonstrate that the draft buprenorphine hydrochloride buccal film product-specific guidance should be revised or that guidance for oral mucoadhesive films to address pH concerns is necessary.

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