USFDA: Novel drug approvals in 2020

USFDA, Novel Drug Approvals

FDA has approved 48 novel drugs in 2020 & here are the most notable approvals

1.Palforzia for peanut allergy 2.Trodelvy for metastatic triple-negative breast cancer 3.Tauvid for Alzheimer disease imaging 4.Nurtec ODT for acute migraine 5.Nexletol for cholesterol and cardiovascular disease 6.Zeposia for multiple sclerosis

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PALFORZIA
Manufacturer: Aimmune Therapeutics, Inc. Approval date: Jan 31, 2020
Indication: PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut

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TRODELVY (sacituzumab govitecan-hziy)
(troh-DELL-vee)
Manufacturer: Immunomedics, Inc.
Approval date: April 22, 2020 Indication: TRODELVY is a drug for the treatment of adults with triple-negative breast cancer that has spread to other parts of the body (metastatic)

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TAUVID (flortaucipir F 18)
(TAAOW-vihd)
Manufacturer: Eli Lilly and Company
Approval date: May 28, 2020 Indication: TAUVID is a radioactive drug used for the visual detection of aggregated neurofibrillary tangles or NFTs in the brain of adult patients with suspected Alzheimer’s disease (AD)

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NURTEC ODT (rimegepant)
NUR-tek ODT
Manufacturer: Biohaven Pharmaceutical Inc.
Approval date: February 27, 2020 Indication: NURTEC ODT is a drug used for treatment of acute migraine with or without aura in adults.

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NEXLETOL (bempedoic acid)
nex’ leh tol
Manufacturer: Esperion
Approval date: February 21, 2020 Indication: NEXLETOL is a drug for the treatment of high LDL cholesterol, which is sometimes referred to as “bad cholesterol”

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ZEPOSIA (ozanimod)
zeh-poe’-see-ah
Manufacturer: Celgene Corporation
Approval date: March 25, 2020 Indication: ZEPOSIA is a drug used for the treatment of adults with relapsing forms of multiple sclerosis