Drugs

Companies Get FDA OK to File 505(b)(2) NDA for Tamsulosin

FDA has given the green light for Female Health Co. and Aspen Park Pharmaceuticals to file a 505(b)(2) NDA for tamsulosin DRS (Delayed Release Sachet), indicated for treating benign prostatic hyperplasia. “Our product is a novel powder which utilizes a proprietary extended release formulation of the existing active ingredient in Flomax,” the companies say. The dosage form is intended to address patients’ difficulty swallowing tablets or capsules. The expedited approval pathway allows the company to reference Flomax’s previous findings of safety and efficacy.

“More specifically, FDA also agreed with our plans to conduct a single bioequivalence study to support the filing of a NDA,” the companies say. “We intend to initiate a three week bioequivalence study in the fourth quarter of this year and submit a NDA in 2017.”

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