Drugs

Taiho Oncology Wants Restrictions on Generic Lonsurf

A 2/10 Taiho Oncology petition asks FDA to impose restrictions on generic drug applicants citing Taiho’s Lonsurf (trifluridine and tipiracil) tablets for oral use as the reference-listed drug. Specifically, the petition asks FDA to:

refuse to approve any ANDA for generic trifluridine and tipiracil tablets that relies on Lonsurf as the reference-listed drug that does not include in the proposed labeling those portions of the Lonsurf label describing pharmacokinetics in and dosage reduction instructions for patients with severe renal impairment and other information from Taiho’s dedicated renal impairment study; and
require applicants seeking approval to market generic trifluridine and tipiracil tablets that rely on Lonsurf as the reference-listed drug to submit a patent certification to a designated patent.

FDA made the renal impairment study a post-marketing requirement, the petition says.

“The approved labeling for Lonsurf includes pharmacokinetic information on patients with severe renal impairment and corresponding required dosage reduction instructions for these patients,” the petition says. “This petition seeks to ensure applicants seeking to market generic versions of Lonsurf are not permitted to carve out this critical safety information in an attempt to circumvent the patent protections afforded to innovators such as Taiho….”

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