Drugs

Virtus Wants 2 NDAs Removed

Virtus Pharmaceuticals is asking that FDA start proceedings to remove two NDAs for potassium chloride oral solution from Lehigh Valley Technologies because the company inappropriately avoided paying $2.2 million in user fees. The petition also asks that the matter be investigated in accordance with the agency’s application integrity policy and that FDA not take action against any other potassium chloride oral solution drug products until the matter has been resolved, even if it cannot immediately withdraw the two NDAs.

The petition says that Lehigh Valley originally sponsored the two NDAs at issue and later transferred sponsorship of one to Pharma Research Software Solution (PRSS) and one to Pharma-Med. Neither company had any experience in drug development, it says, and it appears that the purpose of transferring the sponsorships was to avoid paying user fees. Once the two companies received FDA small business user fee waivers and gained approval of their NDAs, they immediately sold the rights back to Lehigh Valley, which then sold them to other companies. “By working in concert, Lehigh, PRSS, and Pharma-Med avoided paying $2,252,150 in user fees to FDA,” the petition declares.

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