“Companies with limited R&D resources can forgo costly and more risky discovery and development of new chemical entities and instead make incremental innovations to existing drugs. In this manner, companies can use the 505(b)(2) regulatory pathway to repurpose or reposition drugs for new indication,” notes Dr. Babul. A 505(b)(2) NDA may differ from a previously approved reference product, including dosage form, dose, dosing frequency, route of administration or indication.

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