MAYZENT

批准信原文要点

This Prior Approval sNDA provides for the following changes: 1. Addition of a new Contraindication and a new Warnings and Precautions subsection regarding the risk of hypersensitivity.

批准信原文要点

This Prior Approval sNDA provides for updates to Section 7 (Drug Interactions) and Section 12.3 (Pharmacokinetics) of the Prescribing Information to reflect the results of Study A02101, which evaluated the effect of the CYP3A4 inhibitor clarithromycin on the single dose pharmacokinetics (PK), safety, and tolerability of siponimod in healthy subjects with a CYP2C9*1/*3 genotype.

批准信原文要点

This sNDA provides for revisions to the labeling for Mayzent, consistent with our March 1, 2024, letter. ... This information pertains to the risks of cutaneous malignancy, macular edema, and progressive multifocal leukoencephalopathy (PML).

批准信原文要点

under Section 505(o)(4) of the FDCA, of new safety information that we have determined should be included in the labeling for sphingosine 1-phosphate (S1P) receptor modulators, including Mayzent. This information pertains to the risk of Immune Reconstitution Inflammatory Syndrome in the setting of Progressive Multifocal Leukoencephalopathy (PML-IRIS). Supplemental new drug application S-18 provides for revisions to the labeling for Mayzent (siponimod), consistent with our May 16, 2023, Safety Labeling Change Notification Letter.

批准信原文要点

Prior Approval sNDA (S-16) provides for creation of a separate Warnings and Precautions section of the labeling for Mayzent regarding the risk of progressive multifocal leukoencephalopathy (PML). In addition, corresponding changes have been made to Highlights, Section 6 (Adverse Reactions), Section 17 (Patient Counseling Information), and the Medication Guide.

批准信原文要点

This Prior Approval sNDA provides for revisions under the heading “Herpes Viral Infections” under subsection 5.1 (Warnings and Precautions: Infections) of the Prescribing Information, to include updated information regarding cases of varicella zoster virus meningitis and meningoencephalitis reported with Mayzent (siponimod).

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for the introduction of a new 15-count bottle configuration for the 2 mg Mayzent Tablets along with the associated new container labeling and updates to the “United States Prescribing Information” (USPI).

批准信原文要点

This Prior Approval sNDA provides for updates to the Mayzent prescribing information (PI) regarding cutaneous malignancies, including the addition of information pertaining to an increased risk of squamous cell carcinoma associated with Mayzent use and recommended skin examinations prior to or shortly after initiation of Mayzent [Dosage and Administration (2.1), Warnings and Precautions (5.6), Adverse Reactions (6.1), and Patient Counseling Information (17)]. This sNDA also provides for the inclusion of the pregnancy exposure registry information into the PI [Use in Specific Populations (8.1) and Patient Counseling Information (17)] and into the Medication Guide.

批准信原文要点

This Prior Approval sNDA provides for an update to the prescribing information (PI) to include lesser identified CYP2C9 polymorphisms in Use in Specific Populations (8.6) and Clinical Pharmacology (12.5) sections, and to amend the current vaccine recommendations to prescribers in the Warnings and Precautions (5.1) and Drug Interactions (7.4) sections of the PI.

批准信原文要点

This “Changes Being Effected” supplemental new drug application provides for updates to the carton and container labels to change the text for country of origin from “Product of Switzerland” to “Product of Slovenia”.

批准信原文要点

This Prior Approval supplemental new drug application provides for the following changes: • The addition of a 1 mg film-coated tablet formulation. • The addition of a new 7 count (4 day) starter pack configuration for the 0.25 mg film-coated tablets.

批准信原文要点

This Prior Approval supplemental new drug application provides for a new subsection describing the risk of cutaneous malignancies in the Warnings and Precautions section of the Prescribing Information, in addition to related revisions in Section 6.1 (Adverse Reactions; Clinical Trials Experience [Malignancies subsection]), Section 17 (Patient Counseling Information), and the Medication Guide. In addition, this Prior Approval supplemental new drug application provides for revisions to the Juvenile Animal Toxicity Data subsection of Section 8.4 (Use in Specific Populations; Pediatric Use).

批准信原文要点

This Prior Approval supplemental new drug application provides for provides for the following changes: 1) Updates to the Prescribing Information (PI) and carton and container labels as follows: • Addition of language to extend the room temperature in use period to three months for all product configurations • Administrative updates in accordance with PLR guidance like use of abbreviations, and formatting updates 2) Extension of drug product shelf-life to 24 months based on full shelf-life data.