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SPARC gets complete response letter from USFDA for Latanoprost NDA
Source: IRIS | 02 Dec, 2014, 10.12AM
Rating: NAN / 5 stars.
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Sun Pharma Advanced Research (SPARC), a pharma research & drug discovery company, today announced that the US 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.

Shares of the company gained Rs 23.95, or 13.19%, to trade at  Rs 205.50.  The total volume of shares traded  was  574,286 at the BSE (9.59 a.m., Tuesday).

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