Aurobindo Pharma gets USFDA final nod for generic anti-epileptic drug
Aurobindo Pharma has received final nod from the US health regulator to make and market generic anti-epileptic Phenytoin Sodium capsules in America.
By PTI | Updated:
NEW DELHI: Aurobindo Pharma has received final nod from the US health regulator to make and market generic anti-epileptic Phenytoin Sodium capsules in America.
"The company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market extended Phenytoin Sodium capsules USP, 100mg," Aurobindo Pharma said in a statement.
The approved abbreviated new drug application (ANDA) is for the generic version of Pfizer Inc Parke-Davis Division's Dilantin capsules.
The product has an estimated market size of USD 125 million for 12 months ended April 2015, Aurobindo Pharma said quoting IMS data.
The capsules, a anti-epileptic product is indicated for the control of seizures and prevention and treatment of seizures occurring during or following neurosurgery, it added.
The company currently has a total of 199 ANDA approvals (172 final approvals including 9 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.
Aurobindo Pharma stock closed marginally down at Rs 1,276.85 on the BSE.
"The company has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market extended Phenytoin Sodium capsules USP, 100mg," Aurobindo Pharma said in a statement.
The approved abbreviated new drug application (ANDA) is for the generic version of Pfizer Inc Parke-Davis Division's Dilantin capsules.
The product has an estimated market size of USD 125 million for 12 months ended April 2015, Aurobindo Pharma said quoting IMS data.
The capsules, a anti-epileptic product is indicated for the control of seizures and prevention and treatment of seizures occurring during or following neurosurgery, it added.
The company currently has a total of 199 ANDA approvals (172 final approvals including 9 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA.
ADVERTISEMENT
Aurobindo Pharma stock closed marginally down at Rs 1,276.85 on the BSE.
Start a SIP with as low as ₹500 with ET Money App!
Download
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
The Economic Times News App for Quarterly Results, Latest News in ITR, Business, Share Market, Live Sensex News & More.
ADVERTISEMENT
