Pharmaceutical Policy

Reference 1 - Draft Guidance on Dabrafenib Mesylate

Reference 2 - Criteria for waiver of evidence of in vivo bioavailability or bioequivalence

Reference 3 - Prescribing Information for TAFINLAR

Reference 4 - Petition to request a change from a listed drug

Reference 5 - Dabrafenib hard capsule 50 and 75 mg product-specific bioequivalence guidance

Reference 6 - Influence of Drug Properties and Formulation on In Vitro Drug Release and Biowaiver Regulation of Oral Extended Release Dosage Forms

Reference 7 - Improving the Dissolution Rate of the Anticancer Drug Dabrafenib

Reference 8 - A Theoretical Basis for a Biopharmaceutic Drug Classification

Reference 9 - Population pharmacokinetics of dabrafenib

Reference 10 - Dabrafenib in patients with melanoma

Reference 11 - Assessment of the drug interaction potential

Reference 12 - Clinical Pharmacology Review of NDA 202806