Alembic gets final USFDA nod for medication to treat bronchoconstriction ...Middle East

Alembic Pharmaceuticals Ltd on Wednesday said it has received final approval from the US health regulator for its generic version of Arformoterol Tartrate inhalation solution indicated for long-term treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease. The approval by the US Food & Drug Administration (USFDA) for the abbreviated new drug application (ANDA) for Arformoterol Tartrate inhalation solution is for strength of 15 mcg (base)/2 mL unit-dose vial, the company said in a statement. The approved ANDA is therapeutically equivalent to the reference-listed drug product (RLD), Brovana inhalation solution, 15 mcg/2 mL, of Sunovion Pharmaceuticals Inc, it add

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