Drugs

Rayner Wants Generic Omidria Restrictions

Rayner Surgical is petitioning FDA to apply specified restrictions on any ANDA referencing or relying on Omidria (phenylephrine and ketorolac injection) 1%/3%. The 11/27 petition specifically asks that the agency:

decline to accept or approve any ANDA referencing Omidria for a proposed generic product that lacks a buffer;
decline to accept or approve any ANDA referencing Omidria for a proposed generic product that is not comparable to Omidria in pH, buffer capacity, and stability against oxidative degradation;
if a proposed generic product referencing Omidria is allowed to deviate from Omidria’s formulation or differ in key physicochemical properties, FDA should require the ANDA to demonstrate bioequivalence through a suitably powered in vivo clinical endpoint study; and
issue a product-specific guidance that is consistent with the company requests.

The petition says Omidria, which is a sterile aqueous solution, is added to an ocular irrigating solution used during cataract surgery or intraocular lens replacement and for associated post-operative care. It says the drug’s formulation plays a key role in ensuring the product’s safety and efficacy

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