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New Drug Approvals Archive - April 2021

See also: New Indications and Dosage Forms for April 2021

April 2021

Qelbree (viloxazine hydrochloride) Extended Release Capsules

Date of Approval: April 2, 2021
Company: Supernus Pharmaceuticals, Inc.
Treatment for: Attention Deficit Hyperactivity Disorder (ADHD)

Qelbree (viloxazine hydrochloride) is a serotonin norepinephrine modulating agent (SNMA) for the treatment of attention deficit hyperactivity disorder (ADHD) in in adults and pediatric patients 6 years and older.

Nextstellis (drospirenone and estetrol) Tablets

Date of Approval: April 15, 2021
Company: Mayne Pharma
Treatment for: Birth Control

Nextstellis (drospirenone and estetrol) is a progestin and estrogen combination indicated for use by females of reproductive potential to prevent pregnancy.

Jemperli (dostarlimab-gxly) Injection

Date of Approval: April 22, 2021
Company: GlaxoSmithKline
Treatment for: Endometrial Cancer, Solid Tumors

Jemperli (dostarlimab-gxly) is a programmed death receptor-1 (PD-1)–blocking antibody for the treatment of mismatch repair deficient (dMMR) endometrial cancer, and dMMR solid tumors.

Zynlonta (loncastuximab tesirine-lpyl) Injection

Date of Approval: April 23, 2021
Company: ADC Therapeutics SA
Treatment for: Diffuse Large B-cell Lymphoma

Zynlonta (loncastuximab tesirine-lpyl) is a CD19-directed antibody and alkylating agent conjugate indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma.

Kloxxado (naloxone hydrochloride) Nasal Spray

Date of Approval: April 30, 2021
Company: Hikma Pharmaceuticals PLC
Treatment for: Opioid Overdose

Kloxxado (naloxone hydrochloride) nasal spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

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