SPARC gets lit by USFDA

Sun Pharma Advanced Research Company (SPARC) is currently the top gainer on the BSE, up 11.3% at Rs.202, with an intra day high at Rs.207.50. Volumes have surged almost 7 times.

The stock has jumped up after it announced today morning that the U.S. Food and Drug Administration (FDA) has issued a Complete Response letter to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops. 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 believes that this additional information request from the FDA can be addressed on priority.

Latanoprost BAK-free is a preservative-free, once-a-day formulation of the glaucoma medication Latanoprost using SPARC’s novel Swollen Micelle Microemulsion (SMM) technology. Unlike conventional glaucoma eyedrops, Latanoprost BAK-free does not cause or aggravate Ocular Surface Disease (OSD). Prostaglandin analogues like latanoprost are the first line of treatment for glaucoma. Market estimates place Latanoprost usage at as high as 55% of the US glaucoma market.