US 505(b)(2) Regulatory Pathway and Strategies

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505(b)(2) ProcessPotential Regulatory Pathways for Drug ProductsUnder DevelopmentAppropriate for drugproducts that are the sameas approved products505(j)ANDAHybrid between an ANDA[505(j)] and a full NDA[505(b)(1)]505(b)(2) NDA‘Full’ Application – Datapredominantly obtained fromstudies conducted by theSponsor505(b)(1) NDA
505(b)(2) RegulationPotential 505(b)(2) Candidates:• Marketed, unapproved (DESI) drug*• PET drugs (FDG F 18, Ammonia N 13, Sodium Fluoride F 18)• Racemates• Known excipients used as active drugs*• New dosage form• Pharmacokinetic alteration• New indication• New combination• Pro-drug of approved drug* May or may not have an RLD
Page 1 and 2: US 505(b)(2) RegulatoryPathway and
Page 3: Differentiated Products Now Essenti
Page 7 and 8: 505(b)(2) NDAReference Listed Drug
Page 9 and 10: Industry ExamplesHighlighting the B
Page 11 and 12: Corporate StrategyMr. Sims: Actuall
Page 13 and 14: Case Study: Ulesfia TM - Excipient
Page 15 and 16: Pro-Drugs• Fundamental:- Where do
Page 17 and 18: Valacyclovir Regulatory Path• 505
Page 19 and 20: Benefits of 505(b)(2)• Get out of
Page 21 and 22: 505(b)(2) Risks• Uncertain market
Page 23 and 24: 505(b)(2) Risks• Like Generics (5
Page 25: Thank You• Regulatory Sciences Co

US 505(b)(2) Regulatory Pathway and Strategies

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