WASHINGTON (Legal Newsline) - After the FDA allegedly refused to transition a New Drug Application into a Biologics License Application, a pharmaceutical company took legal action against the organization and other related entities on March 24.
The U.S. Court for the District of Columbia received Teva Pharmaceuticals' case against the Food and Drug Administration (FDA), the Commissioner Stephen M. Hahn, the U.S. Department of Health and Human Services, and the Secretary of the department, Alex M. Azar II.
The lawsuit points out that NDAs are required for drugs to be approved, based on the Federal Food, Drug, and Cosmetic Act (FDCA).
But on March 23, almost 100 drugs that were approved for NDA were deemed to be a license “concerning biological products as detailed by the PHSA (Public Health Service Act)."
Despite this, the plaintiffs said that FDA didn’t transition the NDA for their COPAXONE product, which is a drug that helps patients with multiple sclerosis and is considered a biological product.
The plaintiffs described the FDA’s refusal to approve as “arbitrary, capricious, and contrary to law, and it thus should be set aside under the Administrative Procedure Act,” according to the lawsuit.
Teva is seeking a declaration that CPAXONE is a biological product.