FIRDAPSE

批准信原文要点

This Prior Approval supplemental new drug application provides for a new container-closure system for the drug product. The new container-closure system is a blister package where both the blister forming material, and the blister lidding are .

批准信原文要点

This Prior Approval supplemental new drug application provides for an increase in the maximum dose of Firdapse. For adults (any weight) and pediatric patients (45 kg or more), the maximum dose will be increased from 80 mg to 100 mg. For pediatric patients weighing less than 45 kg, the maximum dose will be increased from 40 mg to 50 mg.

批准信原文要点

This Prior Approval sNDA provides for the addition of information from a hepatic impairment study conducted for PMR 3544-3 to subsections 8.7 Use in Specific Populations/Hepatic Impairment and 12.3 Clinical Pharmacology/Pharmacokinetics and information from a 26-week rat carcinogenicity study conducted for PMR 3544-1 to subsection 13.1 Nonclinical Toxicology/Carcinogenesis, Mutagenesis, Impairment of Fertility of the Prescribing Information.

批准信原文要点

This Prior Approval supplemental new drug application provides for the addition of the treatment of pediatric patients with Lambert-Eaton myasthenic syndrome age 6 to less than 17 years to the prescribing information.

批准信原文要点

This Prior Approval supplemental new drug application provides for inclusion of the pregnancy exposure registry information in the labeling.