SPARC gets USFDA approval to treat Leukemia
Sun Pharma Advanced Research Company (SPARC) today informed the bourses that the company has received Orphan Drug Designation from the USFDA for SCO-088 for the Treatment of Patients with Chronic Myeloid Leukemia (CML).
The Orphan Drug Designation program offers orphan status to drugs and biologics which are defined as those intended for the treatment, prevention or diagnosis of a rare disease or condition. Less than 200,000 persons in the US are affected or meets cost recovery provisions of the act.
Orphan Drug Designation will grant seven years of US market exclusivity upon approval of SCO-088 for the treatment of patients with CML. Incentives include waiver of user fee by USFDA and assistance in clinical trial design by USFDA.
Sun Pharma Advanced Research Company (SPARC) is a clinical stage bio-pharmaceutical company which was formed in 2007 through a demerger from Sun Pharma.
The stock of SPARC in today trading session opened at Rs. 117 and touched intra day low of Rs. 112.85. At 12:00 the stock was trading at Rs. 114.55, down by 2.30 per cent.