Drugs

Shutdown Causes Endo Litigation Delay

FDA has asked the DC federal court to continue a stay of Endo’s suit against the agency over bulk compounding of drugs including vasopressin until the government shutdown ends and agency and Justice Department employees are permitted to work again.

The suit previously was stayed until 12/31/18 and FDA had committed to use its best efforts to issue a final clinical need determination for vasopressin on or before that date. Endo had agreed to that stay and did not oppose the government’s motion to continue the stay for the time in which the government lacks appropriations.

The Philadelphia Business Journal reports the company alleges that an FDA interim policy on bulk compounding under Section 503B of the Drug Quality and Security Act is unlawful because it authorized bulk compounding of drugs, including vasopressin, where the applicable legal requirements, including a determination of need, were not satisfied.

An Endo subsidiary, Par Sterile Products, manufactures Vasostrict, the only vasopressin product currently approved by FDA. It is indicated to treat septic shock.

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