BIAXIN XL (nda050697)- (250MG,500MG)

Generic Name	CLARITHROMYCIN	Innovator	ABBVIE INC
Dosage	250MG,500MG
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	ACTICLATE is a tetracycline-class antimicrobial indicated for:  Rickettsial infections  Sexually transmitted infections  Respiratory tract infections  Specific bacterial infections  Ophthalmic infections  Anthrax, including inhalational anthrax (post-exposure)  Alternative treatment for selected infections when penicillin is contraindicated  Adjunctive therapy in acute intestinal amebiasis and severe acne  Prophylaxis of malaria. To reduce the development of drug-resistant bacteria and maintain the effectiveness of doxycycline hyclate and other antimicrobial drugs, ACTICLATE Tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

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
250MG	**	**	-	-	-
500MG	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
No	0

Manufacturing Details of BIAXIN XL