December 26, 2019

Zilretta Receives Label Update

December 26, 2019 –The U.S. FDA has approved updates to the product label for Zilretta® (triamcinolone acetonide extended release injectable suspension), manufactured by Flexion Therapeutics. Zilretta is a synthetic corticosteroid indicated for use as an intra-articular injection to manage osteoarthritis pain
December 26, 2019

Fiasp Indication Expanded to Include Pediatric Patients

December 26, 2019 –The U.S. FDA has approved an expanded indication for Fiasp® (insulin aspart injection), manufactured by Novo Nordisk. Originally approved in 2017 to improve glycemic control in adults who have diabetes mellitus, the product is now also approved to treat pediatric patients.
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
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