GL Pharmtech, Aju Pharmaceuticals' 'Latica Eye Drops' Approved as Korea's 44th New Drug
Promotes Mucus Secretion to Improve Corneal and Conjunctival Epithelial Disorders
Swift Approval Enabled by Dedicated Product Team at the Ministry of Food and Drug Safety
The Ministry of Food and Drug Safety announced on September 8 that it has approved 'Latica Eye Drops 5% (Rekoflavone Hydrate)' from Aju Pharmaceuticals as Korea's 44th new drug.
This medication was co-developed by Aju Pharmaceuticals and GL Pharmtech. It is used to treat adults with dry eye disease by promoting mucus secretion on the ocular surface to improve corneal and conjunctival epithelial disorders. The Ministry of Food and Drug Safety expects that this will provide patients with dry eye disease a broader range of treatment options.
Latica Eye Drops 5% was approved in accordance with the 'New Drug Product Approval and Review Work Procedures' guideline established by the Ministry of Food and Drug Safety last year. The approval process involved the formation of a dedicated product team including 20 expert reviewers, priority review for clinical trials (GCP) and manufacturing and quality management (GMP), and customized face-to-face meetings before and after the product approval application. This close communication with the company enabled a swift approval process.
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The Ministry of Food and Drug Safety stated, "We will continue to enhance the predictability, transparency, and speed of the approval and review process so that safe and effective medicines can be delivered promptly to patients."
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