U.S. Regulatory News September 2021

Table of Contents
September 2021

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

Data collected as of August10, 2021.


MOLECULAR ENTITIES AND BIOLOGS |VETERINARY MEDICINE

 

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

Nexviazyme

avalglucosidase alfa-ngpt

GENZYME CORP

8/6/2021

To treat late-onset Pompe disease.

Saphnelo

ifrolumab-fnia

AstraZeneca

7/30/2021

To treat moderate-to-severe systemic lupus erythematousus along with standard therapy.

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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

Tanovea

Rabacfosadine

VetDC Inc.

July 15, 2021

For treatment of lymphoma in dogs.

Carponfen Tablets

Carprofen

Dechra Veterinary Products LLC

July 7, 2021

For pain relief associated with osteoarthritis in dogs.

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Approved Animal Drug Products