Shares of Sun Pharma Advanced Research Company surged nearly 10 per cent today after US drug regulator FDA issued a complete response letter to its new drug application for Latanoprost BAK—free eyedrops.

The company’s scrip zoomed 9.75 per cent to settle at Rs 199.25 on the BSE. During the day, it surged 14.84 per cent to Rs 208.50.

At the NSE, it gained 9.42 per cent to end the day at Rs 199.15.

In terms of volume, 12.37 lakh shares of the company changed hands at the BSE, while over 45 lakh shares were traded at the NSE during the day.

“While the FDA did not seek any additional information for supporting clinical data, it sought additional information on certain labelling and other deficiencies for processing the NDA,” SPARC said in a filing to the BSE today.

SPARC believes that this additional information request from the FDA can be addressed on priority, it said.

“A complete response letter provides a more consistent and neutral mechanism to convey that USFDA’s initial review of an application is complete and that they cannot approve the application in its present form.

“It provides a more consistent approach to informing applicants of changes that must be made before an application can be approved, with no implication regarding the ultimate approvability of the application,” said Sarabjit Kour Nangra, VP Research — Pharma, Angel Broking.

Under new regulations, USFDA’s Center for Drug Evaluation and Research (CDER) no longer issues “approvable” or “not approvable” letters for a new drug application.

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.

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