Alembic Pharmaceuticals’ joint venture (JV) Aleor Dermaceuticals (Aleor) has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Spray, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex Spray, 0.05% of Galderma Laboratories L.P. (Galderma). Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older.
Clobetasol Propionate Spray, 0.05%, has an estimated market size of $22 million for twelve months ending December 2018 according to IQVIA.
Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 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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