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Alembic Pharmaceuticals has received approval
from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application
(ANDA) Bromfenac Ophthalmic Solution 0.09%. The approved ANDA is therapeutically
equivalent to the reference listed drug (RLD), Bromday Ophthalmic Solution, 0.09%, of Bausch
& Lomb Incorporated (Bausch & Lomb). Bromfenac Ophthalmic Solution 0.09% is indicated
for the treatment of postoperative inflammation and reduction of ocular pain in patients who
have undergone cataract surgery.
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