Drugs

2nd FDA Rejection for Apricus ED Drug

FDA has sent a second complete response letter to Apricus Biosciences on its NDA for Vitaros (alprostadil topical cream) for treating erectile dysfunction. The company says the letter indicates that the agency cannot approve the submission in its present form, identifying deficiencies related to chemistry, manufacturing and controls and certain safety concerns specific to the 2.5% concentration of DDAIP HCl, which is a pharmaceutical ingredient added to topical products to increase penetration through the skin, contained in the current formulation. The company says it is assessing the letter’s content with its regulatory experts, including the information that may be needed to resolve the deficiencies.

The first complete response letter was sent in 2008 and it suggested additional analyses of existing clinical and non-clinical data. Subsequently, an FDA feedback meeting determined that Vitaros, under current regulations, is considered a drug-device combination and, as such, Apricus was advised to meet with the Office of Product Quality to confirm the necessary device engineering and compliance requirements for the NDA resubmission, the company said.

Vitaros contains alprostadil plus a novel excipient. The product delivers rapid onset (generally five to 30 minutes) and treatment duration of about one to two hours, according to the company. Vitaros is intended to provide a first line alternative to oral treatment.

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