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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: Homozygous Familial Hypercholesterolemia

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.

New Drug Approvals Archive

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