US FDA continues effort to promote generic drug approvals

The US Food and Drug Administration has said it will provide new data regarding the eligibility of products for the 180-day exclusivity period for generic drug products.

Published under Paragraph IV of the Patent Certifications list, the agency regularly provides a list of drug products that have been submitted to the FDA, which includes name of the drug product, dosage form, strength, and more.

Under the agency’s new Drug Competition Action Plan (DCAP), which has the ultimate goal of securing more approvals, the FDA now says that additional information regarding 180-day exclusivity for specific drug products will be provided.