Drugs

Endo Drug Compounding Suit Moving Forward

Endo International says it has lifted its temporary stay of litigation against FDA seeking a declaration that the agency’s interim policy on compounding using bulk drug substances under Section 503B of the Drug Quality and Security Act of 2013 is contrary to law because it authorizes bulk compounding of new drugs where the applicable legal requirements are not satisfied and because it is fundamentally inconsistent with the plain language and structure of the Federal Food, Drug, and Cosmetic Act statutory regime. The suit also seeks immediate removal of vasopressin from FDA's Category 1 nominations list to assure that outsourcing facilities do not engage in bulk compounding of vasopressin-containing drug products under Section 503B.

Endo chief legal officer Matthew Maletta says in a news release the firm previously stated that in the event an entity commenced bulk compounding of vasopressin under Section 503B prior to FDA implementation of a new compounding policy, it would lift the stay of litigation against the agency. He said Endo will file a motion for preliminary injunction vacating the listing of vasopressin on FDA's Category 1 bulk drug substances list and preventing FDA from authorizing bulk compounding using vasopressin in a manner that does not comply with applicable laws.

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