Details for New Drug Application (NDA): 213312
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NDA 213312 describes FYARRO, which is a drug marketed by Aadi and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the FYARRO profile page.
The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
The generic ingredient in FYARRO is sirolimus. There are twenty-one drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sirolimus profile page.
Summary for 213312
| Tradename: | FYARRO |
| Applicant: | Aadi |
| Ingredient: | sirolimus |
| Patents: | 5 |
| Formulation / Manufacturing: | see details |
Pharmacology for NDA: 213312
| Mechanism of Action | Protein Kinase Inhibitors mTOR Inhibitors |
| Physiological Effect | Decreased Immunologic Activity |
Medical Subject Heading (MeSH) Categories for 213312
Suppliers and Packaging for NDA: 213312
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| FYARRO | sirolimus | POWDER;INTRAVENOUS | 213312 | NDA | Aadi Bioscience | 80803-153 | 80803-153-50 | 1 VIAL, SINGLE-USE in 1 CARTON (80803-153-50) / 20 mL in 1 VIAL, SINGLE-USE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;INTRAVENOUS | Strength | 100MG/VIAL | ||||
| Approval Date: | Nov 22, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | FOR THE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED UNRESECTABLE OR METASTATIC MALIGNANT PERIVASCULAR EPITHELIOID CELL TUMOR (PECOMA) | ||||||||
| Regulatory Exclusivity Expiration: | Nov 22, 2024 | ||||||||
| Regulatory Exclusivity Use: | NEW PRODUCT | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Apr 15, 2030 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
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