New Drug Approvals Archive - February 2021
See also: New Indications and Dosage Forms for February 2021
February 2021
Posimir (bupivacaine) Solution for Infiltration Use
Date of Approval: February 1, 2021
Company: Durect Corporation
Treatment for: Post-Surgical Pain
Posimir (bupivacaine) is a sustained-release anamide local anesthetic formulation indicated for post-surgical pain reduction following arthroscopic subacromial decompression shoulder surgery.
Tepmetko (tepotinib) Tablets
Date of Approval: February 3, 2021
Company: EMD Serono, Inc.
Treatment for: Non-Small Cell Lung Cancer
Tepmetko (tepotinib) is an oral MET inhibitor for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) harboring mesenchymal-epithelial transition (MET) exon 14 skipping alterations.
Ukoniq (umbralisib) Tablets
Date of Approval: February 5, 2021
Company: TG Therapeutics, Inc.
Treatment for: Marginal Zone Lymphoma; Follicular Lymphoma
Ukoniq (umbralisib) is a dual inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon for the treatment of marginal zone lymphoma (MZL) and follicular Lymphoma (FL).
Breyanzi (lisocabtagene maraleucel) Suspension for Intravenous Infusion
Date of Approval: February 5, 2021
Company: Bristol-Myers Squibb Company
Treatment for: Large B-Cell Lymphoma
Breyanzi (lisocabtagene maraleucel) is a chimeric antigen receptor (CAR) T-cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma (LBCL).
Evkeeza (evinacumab-dgnb) Injection
Date of Approval: February 11, 2021
Company: Regeneron Pharmaceuticals, Inc.
Treatment for: High Cholesterol, Familial Homozygous
Evkeeza (evinacumab-dgnb) is an angiopoietin-like 3 (ANGPTL3) inhibitor indicated as an adjunct to other low-density lipoprotein-cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients, aged 12 years and older, with homozygous familial hypercholesterolemia (HoFH).
Cosela (trilaciclib) for Injection
Date of Approval: February 12, 2021
Company: G1 Therapeutics, Inc.
Treatment for: Small Cell Lung Cancer Myelopreservation Therapy
Cosela (trilaciclib) is a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor myelopreservation therapy for use in patients with small cell lung cancer (SCLC) who are receiving chemotherapy.
Amondys 45 (casimersen) Injection
Date of Approval: February 25, 2021
Company: Sarepta Therapeutics, Inc.
Treatment for: Duchenne Muscular Dystrophy
Amondys 45 (casimersen) is an antisense oligonucleotide for the treatment of patients with Duchenne muscular dystrophy (DMD) who have genetic mutations that are amenable to skipping exon 45 of the Duchenne gene.
Pepaxto (melphalan flufenamide) Injection
Date of Approval: February 26, 2021
Company: Oncopeptides AB
Treatment for: Multiple Myeloma
Pepaxto (melphalan flufenamide) is an anticancer peptide-drug conjugate indicated for use in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma.
Nulibry (fosdenopterin) Injection
Date of Approval: February 26, 2021
Company: BridgeBio Pharma, Inc.
Treatment for: Molybdenum Cofactor Deficiency (MoCD) Type A
Nulibry (fosdenopterin) is a cyclic pyranopterin monophosphate (cPMP) substrate replacement therapy for the treatment of patients with molybdenum cofactor deficiency (MoCD) Type A.
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