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New Drug Approvals Archive - September 2020

See also: New Indications and Dosage Forms for September 2020

September 2020

Onureg (azacitidine) Tablets

Date of Approval: September 1, 2020
Company: Bristol Myers Squibb
Treatment for: Acute Myeloid Leukemia

Onureg (azacitidine) is a nucleoside metabolic inhibitor indicated for the continued treatment of adult patients with acute myeloid leukemia.

Gavreto (pralsetinib) Capsules

Date of Approval: September 4, 2020
Company: Genentech, Inc.
Treatment for: Non-Small Cell Lung Cancer

Gavreto (pralsetinib) is an oral selective RET kinase inhibitor for the treatment of adult patients with metastatic rearranged during transfection (RET) fusion- positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test.

Detectnet (copper Cu 64 dotatate) Injection

Date of Approval: September 3, 2020
Company: RadioMedix Inc.
Treatment for: Positron Emission Tomography Imaging

Detectnet (copper Cu 64 dotatate) is a radioactive diagnostic agent indicated for use with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult patients.

Qdolo (tramadol hydrochloride) Oral Solution

Date of Approval: September 1, 2020
Company: Athena Bioscience, LLC
Treatment for: Pain

Qdolo (tramadol hydrochloride) is an opioid agonist indicated in adults for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Alkindi Sprinkle (hydrocortisone) Oral Granules

Date of Approval: September 29, 2020
Company: Eton Pharmaceuticals, Inc.
Treatment for: Adrenocortical Insufficiency

Alkindi Sprinkle (hydrocortisone granules in capsules for opening) is an immediate-release pediatric formulation of the approved glucocorticoid hydrocortisone for the treatment of adrenocortical insufficiency in infants, children and adolescents.

New Drug Approvals Archive

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