Drugs

Require Studies for Prednisolone Eye Drops: DifGen

DifGen Pharmaceuticals is petitioning FDA to not approve any ANDA for Prednisolone Ophthalmic Solution 1% without the inclusion of long-term stability studies conducted under refrigerated conditions. The 11/7 petition specifically asks that the agency:

require generic applicants to conduct long-term stability studies that specifically demonstrate the product’s stability over its entire shelf life when stored at refrigerated temperatures;
refrain from approving any ANDA for a generic version of the product that does not include data from such long-term stability studies; and
revisit the 8/2 final approval and award of an AB rating to Lupin for its ANDA if it did not include long-term stability studies that specifically demonstrate the product’s stability over its entire shelf life when stored at refrigerated temperatures, including converting the approval to a B rating until the studies are submitted.

“We are concerned that generic versions of the product may not meet the necessary stability requirements for refrigerated conditions, which could compromise the product’s quality, safety, and efficacy,” the petition says. “The stability of the product is critical to its performance, and any impact/change in critical quality attributes of the product could lead to adverse events or therapeutic failures. We believe that the approval of a generic version of the product that does not meet the necessary stability requirements for refrigerated conditions could pose a risk to public health. Therefore, we urge FDA to exercise its authority to ensure that any approved generic version of the product meets the necessary stability requirements to ensure its safety and efficacy.”

DifGen describes Prednisolone Ophthalmic Solution 1% as a sterile, topical, anti-inflammatory agent for ophthalmic use that is indicated to treat steroid-responsive inflammation of the palpebral and bulbar conjunctiva, cornea, and anterior segment of the globe.

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