Alembic Pharmaceuticals has added another key approval to its growing US portfolio, announcing that the US Food & Drug Administration has granted final approval for its Abbreviated New Drug Application for Loteprednol Etabonate and Tobramycin Ophthalmic Suspension, 0.5%/0.3%, in both 5 mL and 10 mL pack sizes. This product is a therapeutic equivalent to Bausch & Lomb’s Zylet Ophthalmic Suspension and is prescribed for steroid-responsive inflammatory eye conditions where a bacterial infection is present or likely. The company noted that full prescribing details remain available on the official product label.
A notable highlight of this approval is the Competitive Generic Therapy (CGT) designation Alembic received for the product. As a result, the company will be eligible for 180 days of CGT exclusivity once the product is launched commercially in the US market—a meaningful advantage in a competitive segment.
The approval also strengthens Alembic’s US regulatory track record. With this latest clearance, the company now holds a cumulative 231 ANDA approvals from the USFDA, including 211 final approvals and 20 tentative ones. The steady expansion of its portfolio underscores Alembic’s long-standing focus on high-quality, complex generics and its growing presence in the US ophthalmic therapeutics space.