Drugs

Mallinckrodt Wants Inomax Designated Drug-Device Combo

Mallinckrodt is asking FDA to designate Inomax (nitric oxide) 800 ppm for inhalation and its 510(k)-cleared specialized delivery system as a drug-device combination product. A 6/30 citizen petition says that Inomax is approved for use in treating neonates greater than 34 weeks gestational age suffering from hypoxic respiratory failure. It notes that the safe use of inhaled nitric oxide is “inextricably linked to the device through which it is administered to patients.”

In addition to asking for a drug-device combination product designation, the petition asks that FDA designate all future inhaled nitric oxide drug products and delivery systems submitted for review as drug-device combinations and require that they be reviewed by CDER and CDRH in a coordinated fashion to ensure that the overall combination product provides the features necessary to assure the safe and effective administration of inhaled nitric oxide.

And it calls on the agency to refuse to receive any Section 505 application citing Inomax as the reference-listed drug and seeking approval of an inhaled nitric oxide drug product unless the NDA/ANDA for the drug product and the 510(k) premarket notification for the associated delivery device collectively provide for 10 safety features listed in the petition that Mallinckrodt says are necessary for the safe and effective administration of inhaled nitric oxide.

Finally, the petition asks the agency to assign a BX rating to follow-on combination inhaled nitric oxide/nitrix oxide delivery system products and to rescind receipt of a Praxair ANDA on the grounds that it was wrongfully received under applicable agency guidance because it proposes use of a drug delivery device that lacks certain important safety features provided by the delivery device for the reference-listed drug, Inomax.

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