Ashland’s injectable pharmaceutical excipient is accepted into the FDA’s New Excipient Review Pilot Program

The FDA has accepted Ashland’s Viatel bioabsorbable mPEG-PDLLA pharmaceutical excipient into the FDA’s New Excipient Review Pilot Program.

Ashland announced on October 31, 2022 that the FDA’s Center for Drug Evaluation and Research’s Office of New Drugs has accepted Ashland Viatel’s bioabsorbable mPEG-PDLLA pharmaceutical excipient into the review cycle of the Pilot Program for New Drugs. FDA excipients.

This is the first time the FDA will allow excipient manufacturers to have certain new excipients reviewed before they are used in drug formulations. The program offers a new avenue for evaluating excipients and could accelerate important public health benefits. Ashland’s vehicle is designed as a polymeric carrier for the delivery of therapeutic pharmaceuticals to target certain tissue sites in the body.

“This prestigious opportunity to participate in the FDA pilot program highlights Ashland’s core life sciences strategy of undiluted focus on innovation in pharmaceutical ingredients,” said Ashok Kalyana, senior vice president and general manager, life sciences, Ashland, in a company press release. “Working with pharmaceutical partners, we are addressing scenarios where manufacturers and drug developers have previously cited difficulties using existing products. Ashland’s innovative excipients efficiently deliver complex drug molecules where and when they’re needed.

Source: Ashland