Drugs

RVL Pharmaceuticals Wants Upneeq Equivalence Requirements

RVL Pharmaceuticals is petitioning FDA to require ANDA applicants and section 505(b)(2) applicants who seek “A” ratings to use appropriate methods to establish that their proposed products are bioequivalent and therapeutically equivalent to Upneeq (oxymetazoline HCl ophthalmic solution) 0/1%. The company’s 6/2 petition asks the agency to take these specific actions:

require an ANDA for a proposed drug referencing Upneeq that is not qualitatively and quantitatively the same as Upneeq, or that differs in certain physicochemical properties, to include data from a comparative in vivo study with appropriate clinical efficacy and safety endpoints;
require an ANDA for a drug product referencing Upneeq that is not qualitatively and quantitatively the same as Upneeq to include data from a comparative in vivo pharmacokinetic study;
require an ANDA product referencing Upneeq to have the same labeling regarding child-resistant packaging as Upneeq;
require an ANDA applicant to demonstrate that any proposed excipient that FDA previously has not approved for use in a human drug product at the proposed exposure level and for an ophthalmic route of administration is safe;
issue a draft product-specific guidance that is consistent with the requests; and
require specified actions from any sponsor of a 505(b)(2) application that references Upneeq.

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