Civica Looks to Take on Soon-To-Be Retired or Withdrawn ANDAs

By halting the withdrawal process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

Civica Rx, a non-profit, non-stock corporation dedicated to maintaining the supply of essential generic medications, released a statement on Jan. 14, 2020 stating they were interested in taking over soon-to-be retired or withdrawn Abbreviated New Drug Applications (ANDAs) from generic drug manufacturers.

According to the release, FDA will withdraw ANDAs approvals if there is minimal activity from the manufacturer. By halting this process, Civica could further its goal to stabilize the supply of generic medications and prevent drug shortages in the United States.

“Part of our manufacturing strategy is to develop our own ANDAs for essential medications, and that work is underway,” said Martin VanTrieste, president and CEO of Civica, in the press 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. This could be a win-win-win for Civica, current ANDA holders and, most importantly, patients who will need these medications in the future.”

“Civica stands ready to take over some of these ANDAs, which the ANDA holders could donate to Civica for potential tax deductions,” VanTrieste added. “By donating their inactive ANDAs, these manufacturers will help ensure patients have quality medications that are available and affordable well into the future.”

Currently, Civica is represented in over 1200 US hospitals and has 18 medications in production for use in hospitals.

Source: Civica