Details for New Drug Application (NDA): 204114
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NDA 204114 describes MEKINIST, which is a drug marketed by Novartis and is included in two NDAs. It is available from one supplier. There are eight 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 204114
| Tradename: | MEKINIST |
| Applicant: | Novartis |
| Ingredient: | trametinib dimethyl sulfoxide |
| Patents: | 8 |
Pharmacology for NDA: 204114
| Mechanism of Action | Protein Kinase Inhibitors |
Suppliers and Packaging for NDA: 204114
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114 | NDA | Novartis Pharmaceuticals Corporation | 0078-1105 | 0078-1105-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1105-15) |
| MEKINIST | trametinib dimethyl sulfoxide | TABLET;ORAL | 204114 | NDA | Novartis Pharmaceuticals Corporation | 0078-1112 | 0078-1112-15 | 30 TABLET, FILM COATED in 1 BOTTLE (0078-1112-15) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET;ORAL | Strength | EQ 0.5MG | ||||
| Approval Date: | May 29, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 16, 2026 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Sep 16, 2030 | ||||||||
| Regulatory Exclusivity Use: | PEDIATRIC EXCLUSIVITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 16, 2030 | ||||||||
| Regulatory Exclusivity Use: | TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY | ||||||||
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