Drugs

Teva Says Copaxone Should Have a BLA

Teva is suing FDA in DC federal court over the agency’s refusal to transition the company’s Copaxone (glatiramer acetate) from an NDA to a BLA on 3/20 as required under the Biologics Price Competition and Innovation Act (BPCIA). The suit says that Copaxone is a leading drug used to treat multiple sclerosis and meets the definition of a “biological product.”

“Because Copaxone is now an eligible ‘biological product,’ the BPCIA required FDA to convert Teva’s approved NDA for Copaxone into a biological-product license by 3/23,” the suit says. “The BPCIA provides FDA with no discretion in the matter. It says an approved NDA for a biological product ‘shall be deemed to be a license for the biological product.’”

Teva says that the agency’s refusal to transition the NDA to a BLA is arbitrary, capricious, and contrary to law and should be set aside under the Administrative Procedure Act.

The company asks the court for an order holding the agency’s action to be unlawful and vacating and setting it aside. It also seeks a court declaration that Copaxone is a biological product under the BPCIA and that the approved NDA is deemed to be a biological license. It further seeks an injunction ordering FDA to take all steps necessary to effect the conversion of the approved Copaxone NDA into a deemed license and to place Copaxone on the final list of approved NDAs for biological products that will be deemed to be BLAs. Finally, it asks the court to award it its costs in pursuing the action and any other relief deemed just and proper.

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