Drugs

Lannett Wants Equivalence Rating for Morphine Product

Lannett is asking FDA to grant an AA therapeutic equivalence (TE) rating for its morphine sulfate oral solution, 100 mg/5 mL. The petition says that the company was told by a CDER staff person that the rating is required to claim the exception for payment of PDUFA establishment and product fees. “We do not believe this TE rating is required by the language of the statute, or FDA guidance, but request it if that is how FDA is administering these provisions,” it says.

According to the petition, the drug had been marketed as an unapproved grandfathered drug and then was submitted to FDA as a 505(b)(2) application. The document includes a legal analysis explaining why the drug meets the criteria for a waiver of PDUFA fees. The company says it was assessed and paid PDUFA establishment and product fees for fiscal year 2015 of $679,570 and for FY 2016 of $699,650.

“If the agency concludes, as we have, that these fees attributable to Lannett’s only NDA qualified for the exception under current law where generic competition exists, we request a refund of these amounts in addition to no future billing invoices sent to Lannett,” the company says.

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