Alembic Pharmaceuticals has received USFDA final approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%. This approval covers both 5 mL and 10 mL versions. The product is therapeutically equivalent to Zylet Ophthalmic Suspension. Alembic was also granted Competitive Generic Therapy (CGT) designation, making it eligible for 180 days of CGT exclusivity upon commercialization.
USFDA Approval Received
Alembic Pharmaceuticals Limited announced that it has received final approval from the US Food & Drug Administration (USFDA) for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%. This approval applies to its Abbreviated New Drug Application (ANDA) for both the 5 mL and 10 mL versions.
Therapeutic Equivalence
The approved ANDA is considered therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, manufactured by Bausch & Lomb Incorporated.
Indication
The Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%, is indicated for steroid-responsive inflammatory ocular conditions where a corticosteroid is needed, as well as in cases of superficial bacterial ocular infection or risk of bacterial ocular infection.
CGT Designation
Alembic received a Competitive Generic Therapy (CGT) designation for this product. As a result, Alembic will be eligible for 180 days of CGT exclusivity after commercialization.
ANDA Approvals
With this latest approval, Alembic Pharmaceuticals now has a cumulative total of 231 ANDA approvals, comprised of 211 final and 20 tentative approvals from the USFDA.
Source: BSE
