Lumakras™ (sotorasib) – New orphan drug approval
The FDA announced the approval of Amgen’s Lumakras (sotorasib), for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC), as determined by an FDA-approved test, who have received at least one prior systemic therapy. May 28, 2021
Lybalvi™ (olanzapine/samidorphan) – New drug approval
Alkermes announced the FDA approval of Lybalvi (olanzapine/samidorphan), for the treatment of Schizophrenia in adults and Bipolar I disorder in adults: (1) as acute treatment of manic or mixed episodes as monotherapy and as adjunct to lithium or valproate or (2) maintenance monotherapy treatment. June 1, 2021
Myfembree® (relugolix/estradiol/norethindrone acetate) – New drug approval
Myovant Sciences and Pfizer announced the FDA approval of Myfembree (relugolix/estradiol/norethindrone acetate), for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. May 26, 2021
Truseltiq™ (infigratinib) – New drug approval
BridgeBio Pharma, through its affiliate QED Therapeutics, and Helsinn Group announced the FDA approval of Truseltiq (infigratinib), for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or other rearrangement as detected by an FDA-approved test. May 28, 2021
Ocaliva® (obeticholic acid) – Safety update
The FDA announced that a new Contraindication will be added to the Ocaliva (obeticholic acid) drug label stating that it should not be used in primary biliary cholangitis (PBC) patients with advanced cirrhosis. May 26, 2021
Brovana® (arformoterol) – First-time authorized brand alternative
Lupin launched an authorized brand alternative of Sunovion’s Brovana (arformoterol) inhalation solution. May 26, 2021
Cosentyx® (secukinumab) – Expanded indication
The FDA approved Novartis’ Cosentyx (secukinumab), for the treatment of moderate to severe plaque psoriasis in patients 6 years and older who are candidates for systemic therapy or phototherapy. May 28, 2021
Nurtec® ODT (rimegepant) – New indication
Biohaven announced the FDA approval of Nurtec ODT (rimegepant), for the preventive treatment of episodic migraine in adults. May 27, 2021
sotrovimab – Emergency use authorization approval
The FDA announced the emergency use authorization (EUA) approval of GlaxoSmithKline (GSK)/Vir Biotechnology’s sotrovimab, for the treatment of mild-to-moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age and older weighing at least 40 kilograms [about 88 pounds]) with positive results of direct severe acute respiratory symptom coronavirus 2 (SARS-CoV-2) viral testing and who are at high risk for progression to severe COVID-19, including hospitalization or death. May 26, 2021
Zeposia® (ozanimod) – New indication
Bristol Myers Squibb announced the FDA approval of Zeposia (ozanimod), for the treatment of moderately to severely active ulcerative colitis (UC) in adults. May 27, 2021
Zipsor® (diclofenac potassium) – Expanded indication
The FDA approved Assertio Therapeutics’ Zipsor (diclofenac potassium) capsule for relief of mild to moderate acute pain in adult and pediatric patients 12 years of age and older. May 25, 2021