Drugs

FDA Denies Without Comment Taiho Lonsurf Petition

Facing a 150-day deadline to respond, FDA has denied without comment specific requests made in a Taiho Oncology petition received 4/28 concerning its Lonsurf (trifluridine and tipiracil) tablets. The response says the petition asked FDA to:

refrain from filing or approving any ANDA or 505(b)(2) application for a generic form of Lonsurf that does not reference Lonsurf and include certifications to all the Lonsurf patents in the Orange Book;
not approve any ANDA or 505(b)(2) application for a generic version of Lonsurf if the application includes a statement that the applicant is not seeking approval of an application containing an indication or other aspect of labeling protected by patent or exclusivity; and
require labeling for any generic version of Lonsurf tablets to include all information related to Warnings, Precautions, and other safety-related information that is included in the Lonsurf labeling.

The agency letter says the Taiho focus is on the completion of study TAS-102-107 and the approvability of generic versions of Lonsurf that carve out labeling information related to dose adjustments in severely renally impaired patients.

“Taiho states that FDA should not allow applicants that reference Lonsurf to carve-out this important information out of the labeling as the resultant labeling will make the proposed generic product less safe and effective than the reference product,” FDA says. “Taiho maintains that if the labeling of a drug product approved through an ANDA or 505(b)(2) application that references Lonsurf could omit dosing information concerning severely renally impaired patients, prescribers would be deprived of vital information required for the safe prescription of generic versions of Lonsurf to patients with severe renal impairment.”

FDA notes that it has not made a final determination on whether to approve or not approve any ANDA or 505(b)(2) application referencing or relying on Lonsurf and does not need to respond to the specific Taiho requests until it does act on such an application.

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Overton Confirmation Remains Uncertain After Senate Hearing

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FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

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FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

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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