BETHKIS (nda201820)- (300MG/4ML)

Generic Name	TOBRAMYCIN	Innovator	CHIESI
Dosage	300MG/4ML
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2023-Mar-17	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BETHKIS is an inhaled aminoglycoside antibacterial indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
300MG/4ML	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of BETHKIS