April 23 (Reuters) - Grace Therapeutics said on Thursday the U.S. Food and Drug Administration declined to approve its drug for a rare type of stroke, citing deficiencies in chemistry, manufacturing and controls and non-clinical data.
In its complete response letter, the FDA referenced specific issues in the chemistry, manufacturing and controls (CMC) and non-clinical sections of the company's application. Grace said it can address these in a resubmission.
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Those items relate to leachables data for product packaging, non-clinical product toxicology risk assessments and product manufacturing deficiencies at the contract manufacturing organization, the company said.
Leachables are chemical compounds that migrate from packaging, manufacturing equipment or delivery systems into a drug.
(Reporting by Puyaan Singh in Bengaluru; Editing by Tasim Zahid)