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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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