SPARC rallies over 14% on receiving CRL from USFDA for Latanoprost NDA

NEW DELHI: Sun Pharma Advanced Research Company Ltd (SPARC) rallied as much as 14.2 per cent in intraday trade on Monday, after the international pharmaceutical company announced that the US Food and Drug Administration (FDA) has issued a Complete Response letter (CRL) to its New Drug Application (NDA) for Latanoprost BAK-free eyedrops.

The stock ended the day at Rs 199.25; up 9.75 percent, on the BSE.

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, the Indian pharmaceutical company said in a filing with BSE.

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.