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FDA has accepted Ashland’s Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient into the FDA Novel Excipient Review Pilot Program.
Ashland announced on Oct. 31, 2022 that FDA’s Center for Drug Evaluation and Research’s Office of New Drugs has accepted Ashland Viatel bioresorbable mPEG-PDLLA pharmaceutical excipient in the review cycle of the FDA Novel Excipient Review Pilot Program.
This is the first time FDA will allow excipient manufacturers to obtain review of certain novel excipients prior to their use in drug formulations. The program offers a new pathway to evaluate excipients and could quicken important public health benefits. Ashland’s excipient is intended as a polymeric carrier for the delivery of therapeutic pharmaceuticals to target certain tissue sites within the body.
“This prestigious opportunity to participate in the FDA pilot program shines a spotlight on Ashland’s life sciences core strategy of undiluted attention to 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’re addressing scenarios where manufacturers and drug developers have previously cited difficulty using existing products. Ashland’s innovative excipients effectively deliver complex drug molecules whereand when they're needed.”