505(b)(2) Application (505(b)(2))

An FDA new drug application pathway that permits reliance on the agency's previous findings of safety and efficacy for a listed drug, combined with new studies conducted by the applicant. Commonly used for new formulations, new dosage forms, new combinations, or new indications of previously approved drugs. Offers a faster and less expensive route than a full NDA while requiring more data than an ANDA.

例

• Sumatriptan nasal spray (new route vs tablet)
• Oxycontin abuse-deterrent reformulation
• Colchicine (Colcrys) for gout — new clinical data for old drug