Skip to Content

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.

FDA Approves Onureg (azacitidine tablets) as Continued Treatment for Adults in First Remission with Acute Myeloid Leukemia
Onureg (azacitidine) FDA Approval History

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

2020: January, February, March, April, May, June, July, August, September, October, November, December
2019: January, February, March, April, May, June, July, August, September, October, November, December
2018: January, February, March, April, May, June, July, August, September, October, November, December
2017: January, February, March, April, May, June, July, August, September, October, November, December
2016: January, February, March, April, May, June, July, August, September, October, November, December
2015: January, February, March, April, May, June, July, August, September, October, November, December
2014: January, February, March, April, May, June, July, August, September, October, November, December
2013: January, February, March, April, May, June, July, August, September, October, November, December
2012: January, February, March, April, May, June, July, August, September, October, November, December
2011: January, February, March, April, May, June, July, August, October, November, December
2010: January, February, March, April, May, June, July, August, September, October, November, December
2009: January, February, March, April, May, June, July, August, September, October, November, December
2008: January, February, March, April, May, June, July, August, September, October, November, December
2007: January, February, March, April, May, June, July, August, September, October, November, December
2006: January, February, March, April, May, June, July, August, September, October, November, December
2005: January, February, March, April, May, June, July, August, September, October, November, December
2004: January, February, March, April, May, June, July, August, September, October, November, December
2003: January, February, March, April, May, June, July, August, September, October, November, December
2002: January, February, April, May, July, August, October, November, December

More News Resources

Subscribe to our Newsletter

Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Recently Approved

Gemtesa
Gemtesa (vibegron) is a once-daily beta-3 adrenergic agonist indicated for the...
Ebanga
Ebanga (ansuvimab-zykl) is a monoclonal antibody for the treatment of Zaire...
Orgovyx
Orgovyx (relugolix) is an oral gonadotropin-releasing hormone (GnRH)...
Riabni
Riabni (rituximab-arrx) is a CD20-directed cytolytic antibody biosimilar to...

More drug approvals

Subscribe to our newsletters

Drugs.com provides accurate and independent information on more than 24,000 prescription drugs, over-the-counter medicines and natural products. This material is provided for educational purposes only and is not intended for medical advice, diagnosis or treatment. Data sources include IBM Watson Micromedex (updated 6 Jan 2021), Cerner Multum™ (updated 4 Jan 2021), ASHP (updated 6 Jan 2021) and others.