Drug News

Stay up-to-date on the latest drug news. Learn about new drug approvals, labeling changes, expanded indications, recalls, and approvals of generic formulations. These drug news updates are compiled from the latest information from Facts & Comparisons® and the U.S. Food and Drug Administration.

DRUG NEWS
(Updated August 5, 2020)

The FDA has approved the following drugs:
  • Metyrosine oral capsules, the first generic version of Demser, to treat patients with pheochromocytoma for preoperative preparation of patients for surgery, management of patients when surgery is contraindicated, and chronic treatment of patients with malignant pheochromocytoma.
  • Monjuvi (tafasitamab-cxix) intravenous injection in combination with lenalidomide to treat adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for autologous stem cell transplant.
The FDA has approved the following new indications:
  • Epidiolex (cannabidiol) oral solution to treat seizures associated with tuberous sclerosis complex in patients one year and older. Epidiolex was already approved to treat seizures associated with two rare and severe forms of epilepsy, Lennox-Gastaut syndrome and Dravet syndrome. This is the only FDA-approved drug that contains a purified drug substance derived from cannabis. 
  • Spravato (esketamine) nasal spray, in conjunction with an oral antidepressant, to treat depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior. Spravato is also approved for treatment-resistant depression in adults. Its labeling includes a Risk Evaluation and Mitigation Strategy (REMS) and a Boxed Warning regarding the risks of sedation, dissociation, abuse and misuse, and suicidal thoughts and behaviors.
  • Tecentriq (atezolizumab) intravenous injection, in combination with cobimetinib and vemurafenib, to treat patients with BRAF V600 mutation-positive unresectable or metastatic melanoma. Tecentriq is also approved for urothelial carcinoma, non-small cell lung cancer, triple-negative breast cancer, small cell lung cancer, and hepatocellular carcinoma. 
The FDA has approved the following expanded indications:
  • Evotaz (atazanavir/cobicistat) oral tablets to include the treatment of HIV-1 infection in combination with other antiretroviral agents in pediatric patients weighing at least 35 kg. Evotaz was previously approved to treat HIV-1 infection in combination with other antiretroviral agents in adults.
  • Prezcobix (darunavir/cobicistat) oral tablets to include the treatment of HIV-1 infection in treatment-naïve and treatment-experienced pediatric patients weighing at least 40 kg with no darunavir resistance associated substitutions (V11I, V32I, L33F, I47V, I50V, I54L, I54M, T74P, L76V, I84V, L89V). 
  • Stelara (ustekinumab) injection to include the treatment of moderate to severe plaque psoriasis in patents 6 years and older who are candidates for phototherapy or systemic therapy. Stelara was previously approved to treat  moderate to severe plaque psoriasis in patients 12 years and older who are candidates for phototherapy or systemic therapy, moderately to severely active Crohn disease in adults, active psoriatic arthritis (as monotherapy or in combination with methotrexate) in adults, and moderately to severely active ulcerative colitis in adults.
 

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