Drugs

Vifor Asks Complex Drug Copy Requirements

Vifor Pharma, which manufactures a number of complex drugs to treat iron deficiency, is asking FDA “to take critical steps regarding the approval and therapeutic equivalence of safe and effective follow-on harder-to-copy complex drugs.” Specifically, the firm’s petition says, FDA should make clear to its stakeholders that the ANDA approval pathway under Section 505(j) of the Federal Food, Drug, and Cosmetic Act (FFDCA) is not appropriate for follow-on versions of certain harder-to-copy complex drugs identified by FDA.

“Any FDA effort to approve these follow-on harder-to-copy complex drugs under Section 505(j) of the FFDCA is contrary to the plain language of the statute and poses significant risks to patients,” the Vifor says. “Instead, approvals and therapeutic equivalence determinations for harder-to-copy complex drugs must be made pursuant to Section 505 (b)(2) and must include clinical studies.”

Vifor asks that FDA:

issue guidance and publicly affirm that the ANDA approval pathway is not appropriate for harder-to-copy complex drugs already identified by FDA, and
use its planned guidance on therapeutic equivalence for follow-on drugs approved pursuant to Section 505(b)(2) to make clear that a follow-on harder-to-copy complex drug may be determined to be therapeutically equivalent to the reference-listed drug when the two drugs meet the existing criteria: same active ingredient; same route of administration, dosage form, and strength; same clinical effect and safety profile; and been shown to be bioequivalent, demonstrated through data from clinical studies.

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