USFDA: Original New Drug Application (NDA and BLA) Approvals November 2011

Drug Name and FDA Appl.	Active Ingredients	NDA Chem. Type *	Review Classifi- cation **	Company
XARELTO (NDA # 202439)	RIVAROXABAN		S	JANSSEN PHARMA
LEVETIRACETAM IN SODIUM CHLORIDE INJECTION (NDA # 202543)	LEVETIRACETAM	3	S	H Q SPECIALITY PHARMA CORP
FORFIVO XL (NDA # 022497)	BUPROPION HYDROCHLORIDE	3	S	INTELGENX CORP.
MORPHINE SULFATE (NDA # 202515)	MORPHINE SULFATE	7	S	HOSPIRA INC
JAKAFI (NDA # 202192)	RUXOLITINIB	1	P	INCYTE CORP
ATAZANAVIR SULFATE AND RITONAVIR (NDA # 022282)	ATAZANAVIR SULFATE; RITONAVIR	4	P	MATRIX LABS LTD
ERWINAZE (BLA # 125359)	asparaginase Erwinia chrysanthemi			EUSA PHARMA USA
EYLEA (BLA # 125387)	AFLIBERCEPT			REGENERON PHARMACEUTICALS
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE (NDA # 202157)	LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE	5	S	HETERO LABS UNIT III
INTERMEZZO (NDA # 022328)	ZOLPIDEM TARTATE	3	S	TRANSCEPT PHARMS

* NDA Chemical Types
Number	Meaning
1	New molecular entity (NME)
2	New ester, new salt, or other noncovalent derivative
3	New formulation
4	New combination
5	New manufacturer
6	New indication
7	Drug already marketed, but without an approved NDA
8	OTC (over-the-counter) switch

​

** Review Classification
Letter	Meaning
P	Priority review drug: A drug that appears to represent an advance over available therapy
S	Standard review drug: A drug that appears to have therapeutic qualities similar to those of an already marketed drug
O	Orphan drug