Bioanalytical validation and PK data package Locked Bioanalytical validation and PK data package
Manufacturing/testing facility readiness and establishment evaluation Locked Manufacturing/testing facility readiness and establishment evaluation
Pyridoxine HCl API and DMF readiness Locked Pyridoxine HCl API and DMF readiness
Delayed-release dissolution method and acceptance criteria Locked Delayed-release dissolution method and acceptance criteria
Drug-substance/product identity, stability, and expiry resolution Locked Drug-substance/product identity, stability, and expiry resolution
Genotoxicity evidence synthesis Locked Genotoxicity evidence synthesis
Nonclinical 505(b)(2) bridge to Bendectin Locked Nonclinical 505(b)(2) bridge to Bendectin
Prescribing information and patient labeling finalization Locked Prescribing information and patient labeling finalization
ADME, intrinsic-factor, and drug-interaction assessment Locked ADME, intrinsic-factor, and drug-interaction assessment
Nonclinical pharmacology/PK/ADME literature assessment Locked Nonclinical pharmacology/PK/ADME literature assessment
Carcinogenicity evidence synthesis Locked Carcinogenicity evidence synthesis
Repeat-dose toxicity evidence synthesis Locked Repeat-dose toxicity evidence synthesis
Reproductive/developmental toxicity evidence synthesis Locked Reproductive/developmental toxicity evidence synthesis
Study 02163: relative bioavailability Locked Study 02163: relative bioavailability P
Study 02191: legacy food-effect bioavailability Locked Study 02191: legacy food-effect bioavailability P
Study 70294: commercial-formulation food effect Locked Study 70294: commercial-formulation food effect P
Study 70381: single- and multiple-dose PK Locked Study 70381: single- and multiple-dose PK P P
DIC-301: pivotal Phase 3 efficacy and safety Locked DIC-301: pivotal Phase 3 efficacy and safety P S S
Primary endpoint: PUQE change at Day 15 Locked
PMR 2033-1: pregnant adolescents 12 to 17 years Locked PMR 2033-1: pregnant adolescents 12 to 17 years
Original NDA 021876 submission Locked Original NDA 021876 submission
FDA refused to file NDA 021876 Locked
Fast Track designation confirmed Locked
Class 2 resubmission of NDA 021876 Locked Class 2 resubmission of NDA 021876
FDA clinical inspection review Locked FDA clinical inspection review
Dissolution-criteria IR response Locked
FDA approval of Diclegis Locked
FDA Type B Pre-NDA meeting Locked
Bendectin prior FDA findings and historical human evidence Locked
DIC-301 controlled efficacy evidence Locked
Efficacy in nausea and vomiting of pregnancy Locked
Bendectin reliance remains scientifically appropriate Locked
Fallback: primary reliance on modern commercial-formulation PK Locked
Legacy PK assay reliability: Studies 02163 and 02191 Locked
Integrated clinical and postmarketing safety evidence Locked
CMC dissolution, stability, and specification deficiencies Locked
Clinical site inspection assessment Locked
DIC-301 site documentation and missing records Locked
Small effect and sensitivity-analysis inconsistency Locked
Commercial-formulation PK and food-effect evidence Locked
Scheduled/titrated dosing and food instruction Locked
CMC, biopharmaceutics, and facility acceptance Locked
505(b)(2) scientific bridge to Bendectin Locked
Residual nonclinical data gaps Locked
RLD and literature-based nonclinical safety package Locked
Acceptable pregnancy safety basis Locked
Pediatric evidence gap in pregnant adolescents Locked
Treatment option after conservative management fails Locked
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