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New Drug Approvals Archive - March 2021

See also: New Indications and Dosage Forms for March 2021

March 2021

Azstarys (dexmethylphenidate and serdexmethylphenidate) Capsules

Date of Approval: March 2, 2021
Company: KemPharm, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Azstarys (dexmethylphenidate and serdexmethylphenidate) is a central nervous system (CNS) stimulant indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients 6 years of age and older.

Fotivda (tivozanib) Capsules

Date of Approval: March 10, 2021
Company: AVEO Oncology
Treatment for: Renal Cell Carcinoma

Fotivda (tivozanib) is a vascular endothelial growth factor receptor (VEGFR) tyrosine kinase inhibitor (TKI) indicated for the treatment of adult patients with relapsed or refractory advanced renal cell carcinoma (RCC) following two or more prior systemic therapies.

Kimyrsa (oritavancin) for Injection

Date of Approval: March 12, 2021
Company: Melinta Therapeutics, LLC
Treatment for: Skin and Structure Infection

Kimyrsa (oritavancin) is a lipoglycopeptide antibiotic for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSI) caused by designated Gram-positive microorganisms, including methicillin-resistant Staphylococcus aureus (MRSA).

Ponvory (ponesimod) Tablets

Date of Approval: March 18, 2021
Company: Janssen Pharmaceuticals, Inc.
Treatment for: Multiple Sclerosis

Ponvory (ponesimod) is a selective sphingosine-1-phosphate receptor 1 (S1P1) modulator indicated for the treatment of adults with relapsing forms of multiple sclerosis (MS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

Zegalogue (dasiglucagon) Injection

Date of Approval: March 22, 2021
Company: Zealand Pharma A/S
Treatment for: Hypoglycemia

Zegalogue (dasiglucagon) is a glucagon analog antihypoglycemic agent for the treatment of severe hypoglycemia in diabetes patients aged 6 years and older.

Abecma (idecabtagene vicleucel) Suspension for Intravenous Infusion

Date of Approval: March 26, 2021
Company: Bristol Myers Squibb
Treatment for: Multiple Myeloma

Abecma (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous chimeric antigen receptor (CAR) T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

Roszet (ezetimibe and rosuvastatin) Tablets

Date of Approval: March 23, 2021
Company: Althera Life Sciences, LLC
Treatment for: Hyperlipidemia, Homozygous Familial Hypercholesterolemia

Roszet (ezetimibe and rosuvastatin) is an intestinal cholesterol inhibitor and HMG Co-A reductase inhibitor (statin) combination indicated to reduce low-density lipoprotein cholesterol (LDL-C) in primary non-familial hyperlipidemia and homozygous familial hypercholesterolemia (HoFH).

New Drug Approvals Archive

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