Pro-Pharmaceuticals submits drug info to FDA
Pro-Pharmaceuticals Inc. said today that the Food and Drug Administration has recommended that the company supply chemistry, manufacturing, and controls information about its drug candidate Davanat.
The Newton drug company said the FDA responded by letter to questions from Pro-Pharmaceuticals to discuss the submission of a new drug application for Davanat, a target delivery technology that the company claims enhances the safety and effectiveness of a variety of FDA-approved drugs.
In its letter, the FDA recommended that Pro-Pharmaceutical provide the chemistry, manufacturing, and controls information necessary to support a new drug application, the company said.
Pro-Pharmaceuticals wants to be able to use Davanat "as a functional excipient to be co-administered with 5-Fluorouracil to treat cancer patients."
Also known as 5-FU, 5-Fluorouracil is one of the most widely used chemotherapy drugs in the world, the company said.
(By Chris Reidy, Globe staff)
