Drug firm Strides Arcolab today said it had received approval from the US health regulator to market Midazolam injections, a general anaesthetic, in the American market.
The company has received approval from the US Food and Drug Administration (USFDA) for Midazolam injection USP in strengths of 1 mg/ml, packaged in 10mg/10ml multiple-dose vials, and 5mg/ml, packaged in 25 mg/5ml and 50 mg/10ml multiple-dose vials, Strides Arcolab said in a statement.
According to IMS data released in September, 2010, the total market for Midazolam in the USA is nearly $51 million.
Midazolam, a general anaesthetic, is offered as a sterile, non-pyrogenic parenteral dosage form for intravenous or intra-muscular injections, it said.
Strides had earlier received USFDA approval for Midazolam injections in strengths of 1 mg/mL (2, 5ml) and 5mg/ml (1, 2 ml) single-dose vials, it added.
"Strides is now in a position to address over 95% of the sterile injectable market for Midazolam and will begin commercialisation of Midazolam injections in Q3," it said.
Midazolam would be launched under the partnership between Strides and Sagent Pharmaceuticals, wherein Strides is developing and supplying more than 25 injectable products for the USA market, which will be marketed by Sagent, it added.
Shares of Strides Arcolab were being quoted at Rs 386.30 apiece in late afternoon trade on the Bombay Stock Exchange today, down 1.78% from their previous close.