AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) (NDA219616)- (EQ 0.8MG BASE;EQ 200MG BASE)

Generic Name	AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE	Innovator	VERASTEM INC
Dosage	EQ 0.8MG BASE;EQ 200MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2042-Dec-29	NCE Excl Expiry	2030-May-08
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	AVMAPKI FAKZYNJA CO-PACK, a combination of avutometinib and defactinib, each kinase inhibitors, is indicated for the treatment of adult patients with KRAS-mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	0	0

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.8MG BASE;EQ 200MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)