Drugs

FDA Extends Review of Lipocine Testosterone Product

FDA has extended its review of a Lipocine NDA resubmission for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult males for conditions associated with hypogonadism. The agency had set a user fee review action date of 8/28, and now FDA says it will make its decision the week of 11/30.

The NDA was resubmitted in March following an 11/2019 complete response letter that said Lipocine’s drug efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations (Cmax), the company said at the time. It also said that FDA did not identify any specific issues relating to the chemistry, manufacturing and controls. The resubmission “incorporates a reanalysis of existing data based on written feedback to address the single remaining deficiency discussed in the post action meeting with the FDA,” it says.

In 2017, the agency sent a complete response letter that identified NDA deficiencies related to the dosing algorithm for the label, noting that the titration scheme for clinical practice was significantly different from the titration scheme used in the Phase 3 trial, leading to discordance in titration decisions between the trial and real-world clinical practice.

That NDA submission went before an advisory committee meeting in 2018 (see story) and panel members voted not to recommend approval. In briefing materials, FDA reviewers said it appeared that Tlando had cardiovascular safety concerns because during clinical trials it appeared to raise heart rate and increase systolic blood pressure. Agency cardiologists recommended that Lipocine perform an ambulatory blood pressure monitoring study to further assess the effects of Tlando on blood pressure and heart rate.

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