U.S. Regulatory News December 2021

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Regulatory News

December 2021

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

Data collected as November 2021.

MOLECULAR ENTITIES AND BIOLOGS |VETERINARY MEDICINE

 

MOLECULAR ENTITIES AND BIOLOGS
Drug Name Active Ingredient Company Approval Date FDA-Approved Use on Approval Date

Besremi

ropeginterferon alfa-2b-njft

PharmaEssentia

11/12/2021

To treat polycythemia vera, a blood disease that causes the overproduction of red blood cells.

Scemblix

asciminib

Novartis

10/29/2021

To treat Philadelphia chromosome-positive chronic myeloid leukemia with disease that meets certain criteria.

Tavneos

avacopan

CHEMOCENTRYX

10/7/2021

To treat severe active anti-neutrophil cytoplasmic autoantibody-associated vasculitis.

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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

Optaflexx™ 45

Ractopamine hydrochloride

Virbac AH, Inc

10/2/2021

For increased rate of weight gain in cattle.

CLAVAMOX®

Amoxicillin and clavulanate potassium

Dechra Veterinary Products LLC

October 20, 2021

Skin and soft tissue infections such as wounds, abscesses, cellulitis, superficial/juvenile and deep pyoderma in dogs.

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Approved Animal Drug Products