Drugs

FDA Flags Deficiencies in Aquestive’s Anaphylm NDA

FDA has told Aquestive Therapeutics that deficiencies have been identified in the company’s NDA for Anaphylm that currently preclude labeling and post-marketing commitments discussions, though the agency emphasized that its review remains ongoing and no final decision has been made.

In a regulatory update, the company said FDA did not specify the deficiencies in its notification. Chief executive Dan Barber said the company is working to understand and address the issues and underscored that the letter does not represent an approval decision. Anaphylm’s user fee review action target date is 1/31.

According to the company, FDA indicated it does not plan to issue a Discipline Review Letter but may request additional information during the remainder of the review. Aquestive warned that delays in receiving details on the deficiencies could push back a potential approval.

Anaphylm is a sublingual film formulation of an epinephrine prodrug intended for the treatment of severe allergic reactions, including anaphylaxis. The company said the development program demonstrated a pharmacokinetic profile comparable to leading epinephrine auto-injectors and a safety profile consistent with epinephrine.

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