Alembic Pharmaceuticals Ltd announces USFDA Final Approval for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%

Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3% (5 mL and 10 mL). The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Zylet Ophthalmic Suspension, 0.5%/0.3%, of Bausch & Lomb Incorporated. Loteprednol etabonate and tobramycin ophthalmic suspension, 0.5%/0.3%, is indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where superficial bacterial ocular infection or a risk of bacterial ocular infection exists. Refer label for a detailed indication.

Alembic was granted a Competitive Generic Therapy (CGT) designation for this application. With this approval, Alembic is eligible for 180 days of CGT exclusivity upon commercialization.

Alembic has a cumulative total of 231 ANDA approvals (211 final approvals and 20 tentative approvals) from USFDA.

Shares of Alembic Pharmaceuticals Limited was last trading in BSE at Rs. 886.15 as compared to the previous close of Rs. 886.55. The total number of shares traded during the day was 1595 in over 200 trades.

The stock hit an intraday high of Rs. 896.00 and intraday low of 882.50. The net turnover during the day was Rs. 1416092.00.

Source : Equity Bulls

Keywords

AlembicPharmaceuticals INE901L01018 USFDA FinalApproval ANDA LoteprednolEtabonate TobramycinOphthalmicSuspension