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Alembic Pharma gets USFDA final nod for Arformoterol Tartrate inhalation solution


Alembic Pharmaceuticals Limited on Wednesday has introduced that it has acquired last approval from the US Meals & Drug Administration (USFDA) for its Abbreviated New Drug Utility (ANDA) for Arformoterol Tartrate Inhalation Resolution, 15 mcg (base) /2 ml Unit-dose Vial.

The permitted ANDA is therapeutically equal to the reference listed drug product (RlD), Brovana Inhalation Resolution, 15 mcg/2 ml, of Sunovion Prescription drugs Inc. Arformoterol Tartarate Inhalation Resolution is a long-acting beta2-adrenergic agonist (beta2-agonist) indicated for long-term, twice every day (morning and night) administration within the upkeep therapy of bronchoconstriction in sufferers with power obstructive pulmonary illness (COPD), together with power bronchitis and emphysema.

This ANDA has been co-developed in partnership with Orbicular Pharmaceutical Applied sciences Personal Restricted.

Arformoterol Tartrate Inhalation Resolution, 15 mcg (base)/2 ml Unit-dose Vial, has an estimated market measurement of US$ 251 million for twelve months ending Dec 2021 in accordance with IQVIA.

Additional, Alembic has a cumulative complete of 167 ANDA approvals (143 last approvals and 24 tentative approvals) from USFDA, together with this second inhalational ANDA approval.

Alembic Prescription drugs ended at Rs724.90 apiece up by Rs4.65 or 0.65% on the BSE.



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