Strides Arcolab has received two approvals from the US health regulator for the supply of generic injectable Bupivacaine Hydrochloride USP, used as an anaesthetic, in the American market.
“Bupivacaine is the 13th product approved under the Sagent-Strides partnership under which Strides is developing and supplying more than 25 injectable products for the US market, which will be marketed by Sagent,” Strides said in a statement today.
The company has received two abbreviated new drug application (ANDA) approvals from the United States Food and Drug Administration (USFDA) for Bupivacaine Hydrochloride Injection USP, it added.
The company has got the approval to supply the injectable drug in strengths of 0.25 per cent, 0.5 per cent and 0.75 per cent, packaged in 10 mL and 30 mL single dose vials, as well as 0.25 per cent (2.5 mg/mL) and 0.5 per cent (5 mg/mL) 50 mL multiple-dose vials.
Strides expects to launch the product shortly and said: “According to IMS, the 2011 US market for injectable Bupivacaine Hydrochloride approximates to $29 million.”
Bupivacaine hydrochloride is indicated for the production of local or regional anaesthesia or analgesia for surgery, dental and oral surgery and diagnostic and therapeutic procedures, the company said.
Shares of Strides Arcolab were being quoted at Rs 374.50 apiece in the afternoon trade on the BSE today, up 0.81 per cent from their previous close.