Drugs

Natco Opposes Taiho Lonsurf Petition

Natco Pharma says it opposes a 4/28 petition filed by Taiho Oncology asking that FDA take specified actions on an ANDA for a generic version of Lonsurf (trifluridine/tipiracil) tablets. The Taiho petition asked that the agency:

refrain from filing or approving an ANDA for Lonsurf tablets that does not include patent certifications to the Orange Book-listed patents for Lonsurf;
refrain from approving an ANDA referencing Lonsurf as the reference-listed drug if the ANDA includes a so-called section viii statement; and
require that labeling for generic forms of Lonsurf include all information relating to Warnings, Precautions, and other safety-related information that is included in the Lonsurf labeling, including dose adjustments in severe renally impaired patients.

The Natco response asks that all relief requested in the Taiho petition be denied. It says that FDA regulations and case law permit ANDA applicants to carve out approved uses from the proposed ANDA labeling under a section viii statement if the omission does not render the proposed drug product less safe or effective that the reference-listed drug for the conditions of use that remain in the labeling.

“Here,” Natco says, “the omission of dosage recommendations for the patient population having severe renal impairment would not render the proposed trifluridine/tipiracil ANDA product less safe or effective that Lonsurf for the remaining conditions of use, i.e., the other approved patient populations (those with normal renal function and mild or moderate renal impairment).”

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

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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