Drugs

Don’t Approve Eagle Vasostrict ANDA Yet: Par

Par Sterile Products is asking FDA not to approve an Eagle Pharmaceuticals ANDA citing Vasostrict as the reference-listed drug until Eagle makes changes recommended by Par. Par also asks the agency not to approve any pending or future vasopressin ANDA referencing Vasostrict if it has pH release specifications that are the same as or close to the pH stability specifications until it has made changes sought by Par.

In its 11/8 petition, Par says that during a July patent trial over the Eagle ANDA, it came to light that if Eagle manufactures its product at the upper end of the pH release specification in its ANDA, then the pH of Eagle’s product will likely increase above the upper limit set in its stability specification.

“The release specification and the stability specification for Eagle’s ANDA product have a pH range of 3.4 to 3.6,” Par says. “Because the pH of Eagle’s product is likely to increase during its shelf life, Eagle’s ANDA product may be released within the release specification parameters, but the pH will drift upward and outside of the specification during the product’s shelf life, creating potential issues for the stability and immunogenicity of Eagle’s product.”

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