Pharma firm Strides Arcolab today said it has received two approvals from the US health regulator for its lidocaine hydrochloride injection, which is used for treatment of irregular heartbeat patients.
The approval from the United States Food and Drug Administration (USFDA) is for its lidocaine hydrochloride injection USP in single-use vials in the strengths of 20mg/ml, 5mg/ml and 10mg/ml, Strides Arcolab said in a filing to the Bombay Stock Exchange.
"The products will be launched in the near future. We have also filed applications for balance strengths, approval for which are awaited," it added.
According to IMS data, the total US market for lidocaine injections in 2009 was worth approximately $61 million.
"Half of this market will be covered by the two products for which approvals have been received," it said.
This approval was the 50th Abbreviated New Drug Application (ANDA) for the company. Of the 50 approvals, 31 are for sterile products. Furthermore, out of 19 ANDA approvals secured by the company in 2010, 14 were in the steriles space.
Shares of Strides Arcolab were trading at Rs 429.55 in afternoon trade on the BSE today, down 1.07 per cent from the previous close.
The approval from the United States Food and Drug Administration (USFDA) is for its lidocaine hydrochloride injection USP in single-use vials in the strengths of 20mg/ml, 5mg/ml and 10mg/ml, Strides Arcolab said in a filing to the Bombay Stock Exchange.
"The products will be launched in the near future. We have also filed applications for balance strengths, approval for which are awaited," it added.
According to IMS data, the total US market for lidocaine injections in 2009 was worth approximately $61 million.
"Half of this market will be covered by the two products for which approvals have been received," it said.
This approval was the 50th Abbreviated New Drug Application (ANDA) for the company. Of the 50 approvals, 31 are for sterile products. Furthermore, out of 19 ANDA approvals secured by the company in 2010, 14 were in the steriles space.
Shares of Strides Arcolab were trading at Rs 429.55 in afternoon trade on the BSE today, down 1.07 per cent from the previous close.
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