Alembic Pharmaceuticals’ joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Tavaborole Topical Solution, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Topical Solution, 5%, of Anacor Pharmaceuticals, Inc. (Anacor).
Aleor had previously received tentative approval for this ANDA. Tavaborole Topical Solution, 5% has an estimated market size of $82 million for twelve months ending June 2020. Alembic has a cumulative total of 133 ANDA approvals (116 final approvals and 17 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 |
|---|---|
| Sun Pharma. Inds. | 1920.10 |
| Dr. Reddys Labs. | 1177.80 |
| Cipla | 1418.00 |
| Lupin | 2175.00 |
| Zydus Lifesciences | 1187.00 |
| View more.. | |
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