approved_indications FDA Approved Biologics and Pending Applications


insulin aspart
BL 208751


aBL 020918


insulin detemir
BL 021878

Levemir® / Levemir® FlexTouch®

insulin detemir recombinant
BL 021536

Norditropin® FlexPro

BL 021148


insulin aspart recombinant
BL 020986

Novolog® Mix 70/30

insulin aspart protamine recombinant; insulin aspart recombinant
BL 021172


BL 761156


insulin degludec
BL 203314

Xultophy® 100/3.6

insulin degludec; liraglutide
BL 208583


Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.


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