Drugs

FDA Denies Mallinckrodt Inomax Petition Without Comment

FDA has denied a Mallinckrodt petition relating to the company’s Inomax without commenting on whether it will do any or all of the actions the company requested. The response lists the company’s petition requests as:

require that all future inhaled nitric oxide drug products and delivery systems be reviewed by CDER and CDRH in a coordinated fashion;
not approve any application citing Inomax as the reference-listed drug unless the NDA/ANDA for the drug and 510(k) premarket notification for the associated delivery device collectively provide for specified features that the petition asserted are necessary for the safe and effective administration of inhaled nitric oxide;
assign a BX rating to follow-on inhaled nitric oxide/NODS products indicating that they are not therapeutically equivalent to the Inomax combination product; and
rescind receipt of an ANDA proposing use of a drug delivery device that lacks certain important safety features provided by the delivery device for Inomax.

The response says FDA is required to respond to the petition within a specified period of time, but is responding without comment on the specific requests regarding any specific applications because the agency has made no final determination on whether to approve or not approve any 505b)(2) NDA or ANDAs referencing Inomax. The letter says FDA has determined that it is not appropriate for it to take action on the approvability of a specific aspect of an application before taking final action on the whole application.

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