CYTOMEL (nda010379)- (EQ 0.005MG BASE,EQ 0.025MG BASE,EQ 0.05MG BASE)

Generic Name	LIOTHYRONINE SODIUM	Innovator	KING PHARMS
Dosage	EQ 0.005MG BASE,EQ 0.025MG BASE,EQ 0.05MG BASE
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	Expired	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	CYTOMEL is an L-triiodothyronine (T3) indicated for: • Hypothyroidism: As replacement in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism • Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of well-differentiated thyroid cancer • Thyroid Suppression Test: As a diagnostic agent in suppression tests to differentiate suspected mild hyperthyroidism or thyroid gland autonomy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	6

Other Developers

Total Other Developers	13

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 0.005MG BASE	**	**	Up	-	6
EQ 0.025MG BASE	**	**	-	-	6
EQ 0.05MG BASE	**	**	-	-	6

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	6

Manufacturing Details of CYTOMEL