Drugs

Supernus Resubmits NDA for ADHD Drug

Supernus Pharmaceuticals has resubmitted its NDA for SPN-812 for treating attention deficit/hyperactivity disorder (ADHD) in pediatric patients. In 11/2020, FDA issued a complete response letter, citing Supernus’ in-house laboratory that conducts analytical testing, which recently moved to a new location. In the NDA resubmission Supernus says it removed reference to its in-house laboratory and addressed other CRL issues. The company expects the agency will classify the resubmission as Class I (two-month review) or Class II (six-month review).

Meanwhile, in 12/2020, Supernus announced positive results from a Phase 3 study for SPN-812 in adults with ADHD. It plans to submit a supplemental NDA to the agency for treating this patient population in the second half of this year, assuming approval for pediatric-use submission.

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