USFDA final approval received for Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%
By ScoutQuest · · 2 min read
- Product Approved
- Ciprofloxacin and Dexamethasone Otic Suspension USP, 0.3% / 0.1%
- IQVIA Market Size
- US$110 million for the 12 months ending June 2026
- Cumulative ANDA Tally
- 246 (226 final, 20 tentative)
What the company announced
Alembic Pharmaceuticals 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%.
The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Ciprodex Otic Suspension, 0.3% / 0.1%, of Sandoz Inc.
What the medicine is used for
The update lists the indication as treatment of infections caused by susceptible isolates of the designated microorganisms in the following conditions:
- Acute Otitis Media (AOM) in pediatric patients (age 6 months and older) with tympanostomy tubes
- Acute Otitis Externa (AOE) in pediatric (age 6 months and older), adult and elderly patients
The label should be referred to for a detailed indication.
The market it addresses
According to IQVIA, 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 is the size of the overall market for this product, not the company's own revenue from it.
Where this sits in the approval tally
Alembic's cumulative total from USFDA is 246 ANDA approvals — 226 final approvals and 20 tentative approvals.
About the company
Alembic is a vertically integrated research and development pharmaceutical company that has been in healthcare since 1907, headquartered in India, manufacturing and marketing generic pharmaceutical products worldwide. Its research and manufacturing facilities are approved by regulatory authorities of many developed countries including the USFDA. It is one of the leaders in branded generics in India, with brands marketed through a field force of over 5500.
How to read this
A final approval relates to the US market for this specific product and dosage form. The IQVIA figure of US$110 million describes the size of the overall product market over the stated twelve months; how much of it a single supplier captures depends on competition and execution. The disclosure also places the approval in the context of the company's broader ANDA portfolio of 246 approvals.
Also from Alembic Pharmaceuticals
Step-down wholly owned subsidiary Alvesta Pharmaceuticals FZCO incorporated in Dubai, UAE
19 Oct 2026
Alembic Pharmaceuticals Ltd shareholder sells 0.07% stake, holding falls to 2.97%
29 Sep 2026
More numbers
- Estimated market size for the product (IQVIA, 12 months to June 2026)US$110 million
- Cumulative ANDA approvals from USFDA246
- Final ANDA approvals226
- Tentative ANDA approvals20
- Field force marketing the company's brandsover 5500
- Ciprofloxacin strength in the suspension0.3%
- Dexamethasone strength in the suspension0.1%
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