Drugs

Bendeka Exclusivity Covers all Bendamustine Drugs: FDA

FDA says it has concluded that the scope of exclusivity ordered by a federal court for Eagle’s leukemia drug Bendeka extends to all applications containing the same active moiety as Bendeka, bendamustine, and bars approval of any application containing bendamustine for any exclusivity-protected indication starting on the 12/7/15 date of Bendeka’s approval and running for seven years until 12/7/22, unless a sponsor establishes clinical superiority or an exception to exclusivity applies. The determination is in a 12/20 agency letter to applicants for certain products containing bendamustine.

FDA had denied Eagle’s request for orphan drug exclusivity, saying the company had not demonstrated that Bendeka was clinically superior to Cephalon’s Treanda (bendamustine) injection. But the federal court held that Eagle was entitled to exclusivity under the plain language of the law.

“Because the district court’s decision has been appealed, it is possible that the agency’s position will prevail upon appeal, in which case Eagle would not have any orphan drug exclusivity,” the letter says. “Thus, the current actions FDA is taking for affected applications may need to be revised based on the outcome of the appeal.”

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