Cosette Pharmaceuticals, Inc., a fully integrated U.S.-based pharmaceutical company, announced that the U.S. Food and Drug Administration has approved its Abbreviated New Drug Application for the first generic version of CIPRO HC, containing ciprofloxacin 0.2% HCl and hydrocortisone 1% otic suspension. The approval includes 180 days of Competitive Generic Therapy exclusivity, and Cosette has already begun commercial shipments, officially initiating the market exclusivity period.
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This marks the first approved generic version of CIPRO HC in more than 27 years, providing a clinically equivalent and more affordable treatment option for patients and healthcare providers managing acute otitis externa. The launch is expected to improve patient access to this important therapy while offering a cost-effective alternative to the branded product.
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Apurva Saraf, President and CEO of Cosette Pharmaceuticals, said that the company is proud to bring the first approved generic version of CIPRO HC to market under the FDA’s Competitive Generic Therapy pathway. He noted that this represents Cosette’s fourth CGT approval and launch in the past three years and highlights the company’s strong research and development capabilities, efficient operations, and commitment to expanding patient access to essential medications. Saraf added that the product will be manufactured at Cosette’s advanced facility in Lincolnton, North Carolina, and emphasized the company’s ongoing efforts to advance its pipeline to address critical treatment gaps for patients.
According to IQVIA, U.S. annual sales of CIPRO HC for the 12 months ending September 2025 totaled approximately $17.9 million. CIPRO is a registered trademark of Bayer Intellectual Property GmbH and is licensed to Alcon by Bayer Intellectual Property AG.
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