U.S. Regulatory News August 2021

News of recent FDA drug approvals and orphan drug designations for humans and animals.

Data collected as of July 18, 2021.

MOLECULAR ENTITIES AND BIOLOGS |VETERINARY MEDICINE

MOLECULAR ENTITIES AND BIOLOGS

Drug Name	Active Ingredient	Company	Approval Date	FDA-Approved Use on Approval Date
Byvlay	odevixibat	ALBIREO PHARMA INC	7/20/2021	To treat pruritus
Rezurock	belumosudil	KADMON PHARMA LLC	7/16/2021	To treat chronic graft-versus-host disease after failure of systemic therapy
Fexinidazole	fexinidazole	DRUGS FOR NEGLECTED DISEASES INITIATIVE	7/16/2021	To treat human African trypanosomiasis
Kerendia	finerenone	KERENDIA	7/9/2021	To reduce the risk of kidney and heart complications in chronic kidney disease associated with type 2 diabetes

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Novel Drug Approvals for 2021

VETERINARY MEDICINE

Original Approvals

Drug Name	Active Ingredient	Company	Approval Date	FDA-Approved Use on Approval Date
Draxxin KP	Tulathromycin and ketoprofen	Zoetis, Inc.	June 1, 2021	For the treatment of bovine respiratory disease
PARASEDGE™ Multi for Dogs	Imidacloprid and moxidectin	Chanelle Pharmaceuticals Manufacturing Ltd.	June 10, 2021	For the prevention of heartworm disease
Deracoxib Chewable Tablets	Deracoxib	Felix Pharmaceuticals Pvt. Ltd.	June 14, 2021	For the control of pain and inflammation associated with osteoarthritis
CARPROFEN Chewable Tablets	Carprofen	Felix Pharmaceuticals Pvt. Ltd.	June 28, 2021	For the relief of pain and inflammation associated with osteoarthritis

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Approved Animal Drug Products

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