New Drug Approvals Archive - December 2020

December 2020

Ga 68 PSMA-11 () Injection

Date of Approval: December 1, 2020
Company: University of California, San Francisco
Treatment for: Diagnostic

Ga 68 PSMA-11 Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

Orladeyo (berotralstat) Capsules

Date of Approval: December 3, 2020
Company: BioCryst Pharmaceuticals, Inc.
Treatment for: Hereditary Angioedema

Orladeyo (berotralstat) is a plasma kallikrein inhibitor indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in adults and pediatric patients 12 years and older.

Klisyri (tirbanibulin) Ointment

Date of Approval: December 14, 2020
Company: Athenex, Inc.
Treatment for: Actinic Keratosis

Klisyri (tirbanibulin) is a first-in-class dual Src Kinase and tubulin polymerization inhibitor for the topical treatment of actinic keratosis on the face or scalp.

Margenza (margetuximab-cmkb) Injection

Date of Approval: December 16, 2020
Company: MacroGenics, Inc.
Treatment for: Breast Cancer

Margenza (margetuximab-cmkb) is a HER2/neu receptor antagonist indicated, in combination with chemotherapy, for the treatment of adult patients with metastatic HER2- positive breast cancer.

Riabni (rituximab-arrx) Injection

Date of Approval: December 17, 2020
Company: Amgen
Treatment for: non-Hodgkin's Lymphoma, Chronic Lymphocytic Leukemia, Wegener's Granulomatosis, Microscopic Polyangiitis

Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s Lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) (Wegener’s Granulomatosis) and microscopic polyangiitis (MPA).

Orgovyx (relugolix) Tablets

Date of Approval: December 18, 2020
Company: Myovant Sciences
Treatment for: Prostate Cancer

Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the treatment of adult patients with advanced prostate cancer.

Ebanga (ansuvimab-zykl) Injection

Date of Approval: December 21, 2020
Company: Ridgeback Biotherapeutics, LP.
Treatment for: Zaire Ebolavirus Infection

Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire ebolavirus (Ebolavirus) infection in adults and children.

Gemtesa (vibegron) Tablets

Date of Approval: December 23, 2020
Company: Urovant Sciences
Treatment for: Overactive Bladder Syndrome

Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency in adults.