Details for New Drug Application (NDA): 217513
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NDA 217513 describes MEKINIST, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are nine patents protecting this drug. Additional details are available on the MEKINIST profile page.
The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
The generic ingredient in MEKINIST is trametinib dimethyl sulfoxide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the trametinib dimethyl sulfoxide profile page.
Summary for 217513
| Tradename: | MEKINIST |
| Applicant: | Novartis |
| Ingredient: | trametinib dimethyl sulfoxide |
| Patents: | 3 |
Pharmacology for NDA: 217513
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 217513
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEKINIST | trametinib dimethyl sulfoxide | SOLUTION;ORAL | 217513 | NDA | Novartis Pharmaceuticals Corporation | 0078-1161 | 0078-1161-47 | 90 mL in 1 BOTTLE (0078-1161-47) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;ORAL | Strength | EQ 0.05MG BASE/ML | ||||
| Approval Date: | Mar 16, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2030 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
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