FDA Updates

Mylan has launched the first FDA-approved generic version of Biogen’s dimethyl fumarate (Tecfidera) for relapsing forms of multiple sclerosis.

Risdiplam (Evrysdi; Genentech) is the only SMA therapy that can be administered at home.

Episode 8 of Over the Counter discusses the new and exciting modernizations in the medication decision support space.

Esketamine (Spravato; Janssen) CIII nasal spray is the first FDA-approved antidepressant medication that improves depressive symptoms with the first dose in adults with major depressive disorder.

On May 8, 2020, the FDA granted accelerated approval to selpercatinib (Retevmo; Eli Lilly and Company).

The therapy will also be available for individuals with asthma and suspected COVID-19 infection.

The new app feature will also soon function with smart labels, which can be scanned and read aloud.

Xeris Pharmaceuticals’ new glucagon injection (Gvoke HypoPen), a ready-to-use glucagon formulation in a premixed autoinjector, is now available by prescription.

The FDA has granted emergency use authorization to an additional combination diagnostic test for influenza and COVID-19.

The fixed-dose combination of pertuzumab and trastuzumab with hyaluronidase (Phesgo; Genentech) can be administered subcutaneously for patients with HER2-positive breast cancer.

A new computer algorithm might be the next step toward accurate prediction of adverse drug reactions.

Officials with the FDA approved fenfluramine (Fintepla, Zogenix) oral solution, CIV for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older.

The first and only one of its kind, metoclopramide nasal spray offers relief to often debilitating symptoms of the gastrointestinal disease.

On February 27, 2020, the FDA approved an intravenous solution of amisulpride (Barhemsys; Acacia Pharma) to treat and prevent postoperative nausea and vomiting.

EndeavorRx (Akili Interactive), a prescription-only game-based device, is indicated for use in children ages 8 to 12 years old with primarily inattentive or combined-type ADHD who have demonstrated an attention issue.

FDA approval for the secukinumab (Cosentyx, Novartis) for non-radiographic axial spondyloarthritis was based on results from the PREVENT trial, which showed significant reduction in disease activity.

Abbott’s FreeStyle Libre 2 is an integrated continuous glucose monitoring system for adults and children ages 4 and older with diabetes.

Officials with the FDA have approved dolutegravir (Tivicay PD, ViiV Healthcare) dispersible tablets for oral suspension for children who are at least 4 weeks of age and weigh at least 3 kg.

Officials with the FDA have approved imipenem, cilastatin, and relebactam (Recarbrio, Merck) for the treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia. 

Ixekizumab (Taltz, Eli Lilly) is the first interleukin-17A antagonist to be approved for non-radiographic axial spondyloarthritis.

Bristol Myers Squibb announced the commercial US launch of ozanimod (Zeposia) for the treatment of relapsing forms of multiple sclerosis.

Officials with the FDA approved atezolizumab (Tecentriq, Genentech) in combination with bevacizumab (Avastin) for the treatment of patients with unresectable or metastatic hepatocellular carcinoma who have not received prior systemic therapy.

Officials with the FDA have granted priority review for mepolizumab (Nucala, GlaxoSmithKline) in the treatment of patients with hypereosinophilic syndrome.

Dupilumab (Dupixent, Sanofi and Regeneron) is the first biologic medicine approved for treatment of moderate-to-severe atopic dermatitis.

Fam-trastuzumab deruxtecan-nxki (Enhertu, Daiichi Sankyo) is indicated for treating adults with unresectable or metastatic HER2-positive breast cancer who have received 2 or more prior anti-HER2–based regimens in the setting of metastasis.

Officials with the FDA granted Emergency Use Authorization (EUA) to the first diagnostic test that will allow at-home collection of saliva samples for coronavirus disease 2019 (COVID-19) testing.

Officials with the FDA have approved celecoxib oral solution 25 mg/mL (Elyxyb, Dr. Reddy’s Laboratories) for the acute treatment of migraine with or without aura in adults.

Officials with the FDA have approved dapagliflozin (Farxiga, AstraZeneca) to reduce the risk of cardiovascular death and hospitalization in adults with heart failure with reduced ejection fraction, with and without type 2 diabetes.