Allergan Tazoral PACT Program Will Register, Certify Physicians/Pharmacies
This article was originally published in The Pink Sheet Daily
Mandatory pregnancy prevention registry will issue ID numbers upon physician/pharmacist certification and patient qualification. Tazarotene efficacy shown in moderate to severe psoriasis, but not in very severe disease, FDA says. Agency expresses concern about off-label use in acne.
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FDA’s proposal for relabeling of antihypertensive agents is based on prior recommendations by the committee that information on cardiovascular outcomes related to blood pressure lowering be included as class labeling.
FDA’s Oncologic Drugs Advisory Committee will meet in Atlanta to review Bristol’s multi-targeted kinase inhibitor dasatinib for two leukemia indications.