Drugs

FDA Issues Complete Response Letter for Xspray Pharma’s Dasynoc

FDA has issued a complete response letter to Xspray Pharma for its NDA for Dasynoc (dasatinib), the company’s product candidate to treat chronic myeloid leukemia and acute lymphoblastic leukemia. A company statement says the FDA letter relates to the agency’s previously communicated observations about CGMP issues at NerPharMa, Xspray’s third-party manufacturer. The letter also asks Xspray for additional commercial-scale consecutive batch data. The statement says NerPharMa has notified FDA that it has completed its required remediation work.

Company officials say they plan to resubmit the NDA this year and secure a new PDUFA action date. “Importantly,” the company statement says, “FDA has not raised questions regarding Dasynoc’s clinical data, bioequivalence, or stability. Furthermore, the risk of medication error raised in previous complete response letters has been resolved.”

Xspray says Dasynoc has been developed using the company’s patented HyNap technology and is an amorphous formulation of dasatinib. It says the product has demonstrated bioequivalence at a 30% lower dose and is designed to enable concomitant use with acid-reducing medicines, a common co-medication that may affect the absorption of conventional dasatinib.

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