Alembic Pharmaceuticals Limited has announced that it has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%. This approval allows the company to market the therapeutic equivalent of Sandoz Inc.’s Ciprodex Otic Suspension in the US market.
USFDA Final Approval Received
Alembic Pharmaceuticals Limited announced today that it has received the final approval from the U.S. Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA). The approval is for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%.
Product and Market Insight
This approved ANDA is therapeutically equivalent to the reference listed drug product, Ciprodex Otic Suspension, 0.3% / 0.1%, manufactured by Sandoz Inc. The Ciprofloxacin and Dexamethasone Otic suspension is indicated for the treatment of infections caused by susceptible microorganisms in specific conditions, including Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes, and Acute Otitis Externa (AOE) in pediatric, adult, and elderly patients.
Market Opportunity
According to IQVIA data, the estimated market size for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%, was US$110 million for the twelve months ending June 2026. This approval marks a significant addition to Alembic’s product portfolio in the lucrative U.S. market.
Company’s ANDA Approvals
With this latest approval, Alembic Pharmaceuticals has achieved a cumulative total of 246 ANDA approvals from the USFDA, comprising 226 final approvals and 20 tentative approvals. This demonstrates the company’s consistent success in navigating the U.S. regulatory landscape and expanding its generic product offerings.
Source: BSE
