Drugs

Genus Lifesciences Protests FDA Actions on Lannett Application

Genus Lifesciences says FDA applied a different and much more lenient standard to an application submitted by Lannett for its cocaine hydrochloride product that Genus says is substantially similar to its Goprelto product. In an 11/27 letter, Genus says that FDA required it to submit results from several studies as part of its initial NDA submission. “Because Genus was required to submit the renal and hepatic toxicity studies as part of its NDA,” the letter says, “the submission was delayed until 11/23/16.”

Genus says that in the course of conducting the studies, it discovered a “sustained higher exposure of cocaine in the post-absorptive phase and the potential for a cumulative increase in systemic concentrations.” In other words, it says, patients with renal or hepatic impairment are exposed to the active ingredient for a longer period of time after its administration. FDA required the company to include language in the labeling cautioning against administering a second dose of Goprelto to patients with hepatic impairment within 24 hours of the first dose.

The letter says that publicly available data indicate that FDA accepted a Lannett 505(b)(2) application for filing without completed renal and hepatic toxicity studies. Genus also says it appears that Lannett had not completed any pharmacokinetic studies in patients with renal or hepatic impairment before FDA accepted the 505(b)(2) submission for filing.

Genus says such studies should be as material to Lannett’s application as they were to Genus’. It calls on the agency to rescind its decision to accept the Lannett application and refuse to accept for filing any subsequent Lannett application for a cocaine hydrochloride product until the expiration of Genus’ new chemical entity exclusivity.

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