Civica Rx is asking fellow generic drugmakers to aid it in combating drug shortages.
Those drugmakers considering retiring or withdrawing their abbreviated new drug applications, or ANDAs, are being asked to donate them to Civica to speed the manufacturing process, the company said Jan. 14.
ANDAs are submitted to the FDA by generic drugmakers for the review and potential approval of a drug. If an ANDA is approved, the drugmaker is then allowed to make and market the drug.
The FDA periodically withdraws approvals of ANDAs because of manufacturer inactivity. The agency is considering withdrawing nearly 250 ANDAs, according to Civica.
Civica is a nonprofit generic drug company that was formed by several major health systems with the goal of combating shortages of essential drugs. Civica wants to obtain the ANDAs that the FDA is considering withdrawing so it can use them to work toward that goal.
"Part of our manufacturing strategy is to develop our own ANDAs for essential medications, and that work is underway," Martin VanTrieste, president and CEO of Civica said in a news release. "However, developing new ANDAs takes time and we’d be very interested in taking over existing ANDAs for essential medications that have a history of drug shortages."
Read the full news release here.