US 505(b)(2) Regulatory Pathway and Strategies
US 505(b)(2) Regulatory Pathway and Strategies US 505(b)(2) Regulatory Pathway and Strategies
Case Study: Cafcit • Caffeine citrate for treatment of apnea of prematurity (MeadJohnson, NDA 20-793, September 21, 1999)• Development Program:– Submitted 1 double-blind trial in 58 preterm infants and 90 literaturearticles• Human PK studies from literature (19 articles)• Drug-drug interactions from literature (71 articles)– No human PK studies conducted in premature infants• Used plasma caffeine levels from subjects in the study and used special software to dopopulation PK analysisReceived orphan drug status (7 years data exclusivity) and expedited review
Pro-Drugs• Fundamental:– Where does the pro-drug become the RLD?–
- Page 1 and 2: US 505(b)(2) RegulatoryPathway and
- Page 3 and 4: Differentiated Products Now Essenti
- Page 5 and 6: 505(b)(2) RegulationPotential 505(b
- 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: Case Study: Ulesfia TM - Excipient
- 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
Case Study: Cafcit • Caffeine citrate for treatment of apnea of prematurity (MeadJohnson, NDA 20-793, September 21, 1999)• Development Program:– Submitted 1 double-blind trial in 58 preterm infants <strong>and</strong> 90 literaturearticles• Human PK studies from literature (19 articles)• Drug-drug interactions from literature (71 articles)– No human PK studies conducted in premature infants• Used plasma caffeine levels from subjects in the study <strong>and</strong> used special software to dopopulation PK analysisReceived orphan drug status (7 years data exclusivity) <strong>and</strong> expedited review
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