Drugs

FDA Revises Listing of Drugs Needing Generic Competition

FDA is revising a listing that identifies brand drugs that do not have any generic competition. Key changes to the listing include presenting the information more clearly by drug product instead of by active ingredient to help firms identify products for potential development, an agency posting says. The list now also displays dosage forms for the products listed, and it includes additional products not identified in the previous version (6/2017) of the list that have either recently lost exclusivity, or were otherwise not included in the original list.

Additionally, FDA has announced its intention to work with the U.S. Pharmacopeial Convention to “maximize the utility of this list by asking USP to develop or modernize compendial standards to assist generic firms in copying many of the off-patent drug products on this list and to continue to provide useful, clear information to the generic drug industry to help encourage development of important generic medicines and increase access for patients.”

The agency reiterated its June announcement the it intends to expedite the review of any generic drug application for a product on this list to ensure that they come to market as expeditiously as possible. It plans to unveil additional aspects of its Drug Competition Action Plan in the coming months.

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