Drugs

Norwich Sues FDA Over Rifaximin ANDA

Norwich Pharmaceuticals is suing FDA in the DC federal court over its “arbitrary, capricious, and unlawful refusal to grant Norwich’s amended ANDA final approval” for the 550 mg strength of rifaximin (Salix’ Xifaxan) to treat irritable bowel syndrome with diarrhea. The suit says that in an 8/2022 decision, the Delaware federal court held that the proposed labeling in Norwich’s original ANDA for a reduction in the risk of overt hepatic encephalopathy (HE) recurrence in adults would induce the infringement of four claims from three asserted method of use patents. The court said that the original ANDA should not be approved until 10/2/2029, the date the HE patents expire, Norwich says.

The company says it amended the ANDA to carve out the HE indication and no longer seeks approval for that indication.

“FDA based its decision to not grant final approval to Norwich’s amended ANDA on the order from the Delaware district court,” the suit says. “But that decision is irrelevant because Norwich’s amended ANDA does not seek approval for the HE indication…. FDA therefore should have granted final approval to Norwich’s amended ANDA…. FDA’s decision is causing Norwich to suffer irreparable harm by precluding it from realizing its first-mover advantage and is adversely impacting the public by further prolonging any relief to patients and payors of a lower-cost generic rifaximin product for irritable bowel syndrome with diarrhea.”

The suit seeks a court judgment declaring that FDA’s decision to grant only tentative approval to the amended ANDA was arbitrary, capricious, and contrary to law, and an injunction directing the agency to immediately grant Norwich’s amended ANDA final approval.

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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