FDA Wins Suit Over Alvogen Xifaxan Skinny Label Rejection

A district court has ruled against an Alvogen subsidiary challenging the FDA’s rejection of its ANDA for a “skinny version” of Silax Pharmaceuticals’ blockbuster irritable bowel syndrome drug Xifaxan (rifaximin).

Norwich Pharmaceuticals, an Alvogen business unit, had been seeking to carve out the drug’s other indication for reducing the risk of recurrence of hepatic encephalopathy in adults — a decline in brain function caused by severe liver disease — but the FDA found that patent rights held by Silax, a subsidiary of Bausch Health, were valid and infringed.

“Obtaining approval of an ANDA, however, requires more than evidence of bioequivalence, safe manufacturing procedures and proper labeling,” wrote Judge Randolph Moss of the U.S. District Court for the District of Columbia on Wednesday, noting that the “generic drug applicant must also work its way through a maze [of] rules that lie at the intersection of FDA regulation and patent laws.”

The court, in rejecting Norwich’s plea to direct the FDA to immediately approve its ANDA, also found that approval of the company’s ANDA cannot occur earlier than expiration of the patents in question on Oct. 2, 2029.

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