Alembic Pharma today announced that it has received final approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution, 15 mcg (base)/2 mL unit-dose vial. The approved ANDA is therapeutically equivalent to the Reference Listed Drug (RLD) product Brovana Inhalation Solution, 15 mcg/2 mL, of Sunovion Pharma, Alembic Pharma said in a statement. Click for more articles on USFDA Arformoterol Tartarate Inhalation Solution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema, the statement added. It also said that this ANDA has been co-developed in partnership with Orbicular Pharma. NPPA fixes Retail Price of 84 formulations: May 2022 NPPA fixes retail price of Emcure’s HIV drug combination USFDA gives nod to Alembic for this generic solution for Inhalation USFDA gives 10 observations to Sun Pharm CDSCO extends timeline for importing of drugs with shelf life less than 60% FAQs – on Blood Bags and its Testing USFDA gives tentative nod to Glenmark for Calcipotriene and Betamethasone Dipropionate foam IPC releases IP 2022, 92 new monograph, 27 APIs added: Read details USFDA gives tentative approval for this Hypertension drug Latest Notifications regarding Pharmaceuticals
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