International Medical Assistance – Page 87

December 24, 2019

Mycamine Approved for New Indication

December 24, 2019 –The U.S. FDA has approved a new indication for Mycamine® (micafungin for injection), manufactured by Astellas Pharmaceuticals. The product is now indicated to treat candidemia, acute disseminated candidiasis, and Candida peritonitis and abscesses without

December 24, 2019

First Generics for Eliquis Approved

December 24, 2019 –The U.S. FDA has approved the first generics for Eliquis® (apixaban – Bristol-Myers Squibb) tablets. The generics, which are manufactured by Mylan Pharmaceuticals and by Micro Labs, are approved for the same indications as the brand name product.

December 23, 2019

Ubrelvy Approved to Treat Migraines

December 23, 2019 –The U.S. FDA has approved UbrelvyTM (ubrogepant) tablets, manufactured by Allergan, to provide acute treatment of migraine with or without aura in adults. Ubrelvy is the first drug in the calcitonin gene-related peptide (CGRP) receptor antagonist class approved for the acute treatment

December 23, 2019

Conjupri Approved for Hypertension

December 23, 2019 –The U.S. FDA has approved Conjupri® (levamlodipine) tablets, manufactured by CSPC Pharmaceutical Group, for use either alone or in combination with other antihypertensive agents to treat hypertension and lower blood pressure, which can reduce the risk of fatal

December 23, 2019

Dayvigo Approved for Treatment of Insomnia

December 23, 2019 – The U.S. FDA has approved DayvigoTM (lemborexant) to treat adult patients who have insomnia characterized by difficulties with sleep onset and/or sleep maintenance. Insomnia affects approximately 40 million people in the United States each year.

December 23, 2019

Caplyta Receives Approval for Schizophrenia

December 23, 2019 –The U.S. FDA has approved Caplyta® (lumateperone), manufactured by Intra-Cellular Therapies, to treat schizophrenia in adults. Caplyta is an atypical antipsychotic with a unique mechanism of action that targets three different neurotransmitters in the brain – serotonin, dopamine

December 20, 2019

Enhertu Approved to Treat Breast Cancer

December 20, 2019 – The U.S. FDA has approved Enhertu® (fam-trastuzumab deruxtecan-nxki), manufactured by Daiichi Sankyo, to treat adult patients who have unresectable or metastatic HER2- positive breast cancer and have been treated with at least two prior anti-HER2-based regimens in the

December 20, 2019

Lannett Company Voluntarily Recalls Seizure Medication

December 20, 2019 – Lannett Company, Inc., has issued a voluntary recall of two lots of Levetiracetam Oral Solution 100mg/mL due to contamination with Bacillus subtilis identified during evaluation of a raw material used to manufacture the product. Bacillus subtilis is a bacterium regularly found in the