Archive · 11 Dec 2025
Alembic Gets USFDA Nod for Eye Infection Treatment
Alembic Pharmaceuticals, an Indian company, got permission from the US health authorities to make and sell a generic version of a medicine called Loteprednol Etabonate and Tobramycin Ophthalmic Suspension.
This medicine is used to treat eye infections and inflammation.
The US FDA gave this approval, and Alembic will have exclusive rights to sell this medicine for 180 days.
The medicine is similar to a brand-name version called Zylet, made by Bausch & Lomb.
It helps people with certain eye conditions where there is a risk of bacterial infection.
Alembic Pharmaceuticals received USFDA approval for its generic Loteprednol Etabonate and Tobramycin Ophthalmic Suspension.
The drug is used to treat steroid-responsive inflammatory ocular conditions with a risk of bacterial infection.
The approval includes a CGT designation, granting Alembic 180 days of exclusivity upon commercialization.
The approved ANDA is therapeutically equivalent to Zylet Ophthalmic Suspension by Bausch & Lomb.
The drug is available in strengths of 0.5%/0.3% in 5 mL and 10 mL containers.
- Who
- Alembic Pharmaceuticals Ltd
- What
- Received USFDA approval for generic eye infection treatment
- When
- December 11, 2025
- Where
- United States
- Why
- To treat steroid-responsive inflammatory ocular conditions with bacterial infection risk
- Company
- Alembic Pharmaceuticals Ltd
- Approval Received
- USFDA final approval
- Drug Name
- Loteprednol Etabonate and Tobramycin Ophthalmic Suspension
- Strength
- 0.5%/0.3% (5 mL and 10 mL)
- Designation
- Competitive Generic Therapy (CGT)
- Exclusivity Period
- 180 days
- Reference Drug
- Zylet Ophthalmic Suspension by Bausch & Lomb Incorporated
- Indication
- Steroid-responsive inflammatory ocular conditions with bacterial infection risk