Improving NDA Approval Odds For New Dosage Forms Of Approved Products

By Angela Drew, PhD, Director, Regulatory Strategy, Olu Aloba, PhD, Vice President, CMC Services, and Vanessa Diniz Atayde, PhD, Senior Associate, Regulatory Affairs

There are numerous reasons why a sponsor may wish to market a new dosage form of an approved product. Aside from the obvious financial benefits to the sponsor, providing a more convenient and/or faster-acting dosage form of a well-chosen drug provides significant benefits for patients.

Examples of new dosage forms include oral solutions and suspensions of drugs that were previously only approved as solid oral dosages forms. Liquids are more appropriate for some pediatric and geriatric populations and for patients with difficulty swallowing. Other products designed to enhance ease of swallowing include chewable or effervescent tablets, oral films, and orally disintegrating granules. Sponsors may wish to market both capsule and tablet forms of their products for patient convenience. Faster-acting oral dosage forms such as buccal lozenges or films are beneficial for indications requiring a rapid onset of action.