Business EconomyPosted at: Mar 22 2019 1:32PM

Alembic Pharma gets USFDA Approval for Azelastine Hydrochloride Ophthalmic Solution, 0.05 pc

Mumbai, Mar 22(UNI)Pharma Major, Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05 pc.
The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Optivar Ophthalmic Solution, 0.05 pc, of Mylan Specialty L.P. (Mylan),company said in a filing with BSE.
Azelastine Hydrochloride Ophthalmic Solution 0.05 pc is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Azelastine Hydrochloride Ophthalmic Solution, 0.05 pc, has an estimated market size of USD 8.5 million for twelve months ending December 2018 according to IQVIA.
Alembic now has a total of 89 ANDA approvals (76 final approvals and 13 tentative approvals) from USFDA.
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Tags: #Alembic Pharma gets USFDA Approval for Azelastine Hydrochloride Ophthalmic Solution # 0.05 pc

Alembic Pharma gets USFDA Approval for Azelastine Hydrochloride Ophthalmic Solution, 0.05 pc

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