 "Aurobindo Pharma gains on USFDA nod for Aripiprazole tablets")
Aurobindo Pharma has moved higher by 4.5% to Rs 785 on the BSE after the drug maker announced it has received the final approval from the US Food & Drug Administration (USFDA) to manufacture and market Aripiprazole Tablets.
“The approved abbreviated new drug applications (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Abilify® tablets 2mg, 5mg, 10mg, 15mg, 20mg and 30mg of Otsuka Pharmaceutical Company, Ltd (Otsuka),” Aurobindo Pharma said in a release.
Aripiprazole Tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The product is ready for launch, it added.
According to IMS, the approved product has an estimated market size of US$7.3 Billion for the twelve months ending August 2015.
At 01:07 pm, the stock was up 4.4% at Rs 784 on the BSE. A combined 1.51 million shares changed hands on the counter on the BSE and NSE so far.
“The approved abbreviated new drug applications (ANDA) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Abilify® tablets 2mg, 5mg, 10mg, 15mg, 20mg and 30mg of Otsuka Pharmaceutical Company, Ltd (Otsuka),” Aurobindo Pharma said in a release.
Aripiprazole Tablets are atypical antipsychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The product is ready for launch, it added.
According to IMS, the approved product has an estimated market size of US$7.3 Billion for the twelve months ending August 2015.
At 01:07 pm, the stock was up 4.4% at Rs 784 on the BSE. A combined 1.51 million shares changed hands on the counter on the BSE and NSE so far.
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