Details for New Drug Application (NDA): 213312

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 six 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.

Summary for 213312

Tradename:	FYARRO
Applicant:	Aadi
Ingredient:	sirolimus
Patents:	6

Pharmacology for NDA: 213312

Mechanism of Action	Protein Kinase Inhibitors mTOR Inhibitors
Physiological Effect	Decreased Immunologic Activity

Medical Subject Heading (MeSH) Categories for 213312

Anti-Bacterial Agents

Antibiotics, Antineoplastic

Antifungal Agents

Immunosuppressive Agents

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:		Patent Expiration:	Apr 15, 2030	Product Flag?	Y	Substance Flag?		Delist Request?

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