Alembic Pharmaceuticals has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Optivar Ophthalmic Solution, 0.05%, of Mylan Specialty L.P. (Mylan). Azelastine Hydrochloride Ophthalmic Solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis.
Azelastine Hydrochloride Ophthalmic Solution, 0.05%, has an estimated market size of $ 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.
Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company, has been at the forefront of Healthcare since 1907.
| Company Name | CMP |
|---|---|
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| Dr. Reddys Lab | 1235.40 |
| Cipla | 1238.30 |
| Zydus Lifesciences | 942.55 |
| Lupin | 2324.25 |
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