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 in a statement.
SPARC believes that this additional information request from the FDA can be addressed on priority, it added.
The company said, 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.
Market estimates place Latanoprost usage at as high as 55% of the US glaucoma market.
The stock opened at Rs 190 and hit a high of Rs 208 on BSE. The counter has seen huge trading volumes with a combined 1.9 million shares changed hands in first 15 minutes of trade as compared an average sub 200,000 shares that were traded daily in past two weeks on NSE and BSE.