Drugs

Braeburn Says Brixadi Can Be Marketed 12/1/20

Braeburn says that in light of the FDA decision to grant its April petition requesting revocation of Indivior’s orphan designation for Sublocade (buprenorphine extended-release) injection, Braeburn’s Brixadi (buprenorphine) weekly and monthly extended-release injection to treat opioid use disorder can be marketed as of 12/1/20. A Braeburn statement says Brixadi was tentatively approved by FDA 12/2018 and was ineligible to be marketed due to a three-year clinical exclusivity period for Sublocade.

Braeburn filed suit to overturn the decision and in 7/2019 a DC federal judge ordered the agency to reconsider the Brixadi application with an expectation that FDA would more clearly define innovation standards and provide clarification about earlier exclusivity decisions, Braeburn says. Braeburn also filed the 4/2019 petition seeking revocation of the Sublocade orphan designation and clinical exclusivity. FDA has now revoked the orphan designation but has upheld the clinical exclusivity through 11/30/20.

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