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New Drug Approvals Archive - May 2021

See also: New Indications and Dosage Forms for May 2021

May 2021

Zynrelef (bupivacaine and meloxicam) Injection

Date of Approval: May 12, 2021
Company: Heron Therapeutics, Inc.
Treatment for: Postoperative Pain

Zynrelef (bupivacaine and meloxicam) is an extended-release, fixed-dose combination of the local anesthetic bupivacaine and the nonsteroidal anti-inflammatory drug (NSAID) meloxicam indicated for the management of postoperative pain.

Empaveli (pegcetacoplan) Injection

Date of Approval: May 14, 2021
Company: Apellis Pharmaceuticals, Inc.
Treatment for: Paroxysmal Nocturnal Hemoglobinuria

Empaveli (pegcetacoplan) is a targeted C3 inhibitor for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).

Rybrevant (amivantamab-vmjw) Injection

Date of Approval: May 21, 2021
Company: The Janssen Pharmaceutical Companies of Johnson & Johnson
Treatment for: Non-Small Cell Lung Cancer

Rybrevant (amivantamab-vmjw) is a bispecific EGF receptor-directed and MET receptor-directed antibody indicated for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test.

Camcevi (leuprolide mesylate) Injection

Date of Approval: May 26, 2021
Company: Foresee Pharmaceuticals
Treatment for: Prostate Cancer

Camcevi (leuprolide mesylate) is a ready-to-use, 6-month depot formulation of the approved gonadotropin releasing hormone (GnRH) agonist leuprolide indicated for the treatment of adult patients with advanced prostate cancer.

Myfembree (relugolix, estradiol and norethindrone acetate) Tablets

Date of Approval: May 26, 2021
Company: Myovant Sciences
Treatment for: Uterine Fibroids

Myfembree (relugolix, estradiol and norethindrone acetate) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen, and progestin combination indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

Pylarify (piflufolastat F 18) Injection

Date of Approval: May 26, 2021
Company: Progenics Pharmaceuticals, Inc.
Treatment for: Positron Emission Tomography Imaging

Pylarify (piflufolastat F 18) is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Truseltiq (infigratinib) Capsules

Date of Approval: May 28, 2021
Company: BridgeBio Pharma, Inc.
Treatment for: Cholangiocarcinoma

Truseltiq (infigratinib) is an FGFR tyrosine kinase inhibitor indicated for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test.

Lumakras (sotorasib) Tablets

Date of Approval: May 28, 2021
Company: Amgen Inc.
Treatment for: Non-Small Cell Lung Cancer

Lumakras (sotorasib) is a KRASG12C inhibitor for the treatment of patients with KRAS G12C-mutated locally advanced or metastatic non- small cell lung cancer (NSCLC), following at least one prior systemic therapy.

Lybalvi (olanzapine and samidorphan) Tablets

Date of Approval: May 28, 2021
Company: Alkermes plc
Treatment for: Schizophrenia, Bipolar Disorder

Lybalvi (olanzapine and samidorphan) is a combination of an established antipsychotic agent (olanzapine) and a novel μ-opioid receptor antagonist (samidorphan) for the treatment of schizophrenia and bipolar I disorder.

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