US health regulator USFDA has not approved Sun Pharma Advanced Research Company's anti-Glaucoma eyedrop.
"US Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops," SPARC said in a BSE filing.
SPARC had sought USFDA approval for Latanoprost BAK-free to sale in the US market.
It said: "While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labeling and other deficiencies for processing the NDA."
SPARC said it believes this additional information request from the FDA can be addressed on priority.
Under new regulations, USFDA's Center for Drug Evaluation and Research (CDER) no longer issues "approvable" or "not approvable" letters when a drug application is not approved.
Instead, CDER issues a "complete response" letter at the end of the review period to let a drug company know of the agency's decision on the application.
Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication using Swollen Micelle Microemulsion (SMM) technology.
Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate Ocular Surface Disease (OSD).
