Drugs

United Therapeutics Petitions FDA to Block Generic Tyvasco

United Therapeutics has petitioned FDA urging it to require strict bioequivalence standards for generic copies of its Tyvaso (treprostinil) inhalation solution. Tyvaso is a drug-device combination product indicated for treating pulmonary arterial hypertension in patients with specific symptoms to increase walk distance.

The petition, filed by the law firm Hogan Lovells, says the agency must refrain from approving an ANDA for a drug-device combination product if it “determines that (a) the proposed generic device and components differ in critical design attributes; (b) differences in the generic delivery system would require patients to be retrained in use of the device; (c) the generic product includes different conditions of use or otherwise requires labeling changes not permitted under section 505(j) of the FDCA; or (d) in order to be eligible for approval, the ANDA would need to contain human factors studies or other clinical trial data beyond what is required to show bioequivalence.

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