ANDA Filing:
All sections have been reviewed
- Chemistry, Manufacturing and Controls (CMC)
- Labeling
- Microbiology
- Bioequivalence
- Other (Packaging, Device)
- Average approval times for generics now >27months*
- Priority approval times ~13months (+/-3m) after acceptance**
- Several generics approved in recent months with similar/later ANDA #s
jmp presentation, page-2
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