Drugs

Supernus Talking with FDA on Two Submissions

Supernus Pharmaceuticals says it received a complete response letter from FDA for its NDA for SPN-812 (viloxazine HCl) to treat attention-deficit hyperactivity disorder in pediatric patients ages 8-17. A company statement says the primary issue cited in the FDA letter related to the firm’s in-house laboratory that conducts analytical testing. Supernus says the lab recently moved to a new location and says it will inform FDA that the NDA does not rely solely on the lab for product release. The company says it will discuss with FDA the steps required to resubmit the NDA.

The statement also says Supernus received a refusal to file letter from FDA for its NDA for SPN-830 (apomorphine infusion pump) for the continuous treatment of motor fluctuations in Parkinson’s disease. FDA indicated the NDA was not sufficiently complete to permit a substantive review, the letter said. The agency asked for certain documents and reports to be submitted in support of the application, Supernus says. It again says it will seek a meeting with FDA to clarify the issues and the steps required to resubmit the NDA.

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

Read more

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