Saptalis Pharmaceuticals Receives FDA Approval for Cyclosporine Ophthalmic Emulsion, 0.05%

Saptalis Pharmaceuticals, LLC is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Cyclosporine Ophthalmic Emulsion, 0.05%. Saptalis’ product is bioequivalent and therapeutically equivalent to the Reference Listed Drug (RLD), Restasis®, marketed by AbbVie, Inc. The product is packaged in sterile, preservative-free single-use vials, each containing 0.4 mL of emulsion in a 0.9 mL LDPE vial. Five vials are sealed in an aluminum pouch, with 6 or 12 pouches per carton, allowing for dispensing in quantities of 30 or 60 vials. Cyclosporine ophthalmic emulsion is indicated to increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca. Increased tear production was not observed in patients currently using anti-inflammatory medications or punctal plugs. According to the latest data from IQVIA/IMS Health, the annual U.S. market for Cyclosporine Ophthalmic Emulsion 0.05% in single-dose vials exceeds $2 billion, with over 250 million vials dispensed annually. “Saptalis is very pleased with the FDA approval of this complex sterile ophthalmic product. This success reflects several years of collaboration between Saptalis and our development and manufacturing partner, Taejoon Pharmaceutical Co., Ltd.,” said Dr. Polireddy Dondeti, President & CEO of Saptalis. About Saptalis Pharmaceuticals: Saptalis is a rapidly growing pharmaceutical company specializing in the development, manufacturing, and commercialization of innovative and generic products in liquid and semi-solid dosage forms. The company operates fully equipped R&D laboratories and a state-of-the-art, FDA-GMP approved commercial manufacturing facility in Hauppauge, NY, supplying a broad range of FDA-approved prescription products to the U.S. market. About Taejoon Pharmaceutical Co., Ltd.: Taejoon is a leading specialty pharmaceutical company based in Korea, with expertise in ophthalmology, image contrast agents (MRI and CT), and gastrointestinal products. Taejoon is an FDA and EU-GMP approved manufacturer, exporting ophthalmic products to the U.S., EU, and Asia. Saptalis expects to launch Cyclosporine Ophthalmic Emulsion under its label in the coming weeks.

The release as fetched from its publisher. saptalis.com ↗