U.S. Regulatory News October/November 2021

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U.S. Regulatory News
October/November 2021

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

Data collected as of September 2021.


MOLECULAR ENTITIES AND BIOLOGS |VETERINARY MEDICINE

 

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

Tivdak

tisotumab vedotin-tftv

SEAGEN

9/20/2021

To treat recurrent or metastatic cervical cancer with disease progression on or after chemotherapy

Exkivity

mobocertinib

Takeda

9/15/2021

To treat locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations.

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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