Strides Arcolab has announced that it has received two ANDA (an Abbreviated New Drug Application) approvals from US FDA for Bupivacaine hydrochloride injections.
The company in a release said Bupivacaine hydrochloride is applied for regional anaesthesia or analgesia for surgery, dental and oral surgery procedures, diagnostic and therapeutic procedures, and for obstetrical procedures.
Bupivacaine is the 13 product approved under the Sagent - Strides partnership.
Bupivacaine Hydrochloride Injection, comes in different dosages - 0.25 per cent, 0.5 per cent and 0.75 per cent packaged in 10 mL and 30 mL Single-dose Vials (Preservative Free).
According to IMS, the 2011 US market for Injectable Bupivacaine Hydrochloride approximates to $29 million. The product is expected to be launched shortly.
Strides is developing and supplying more than 25 injectable products for the US market which are expected to be marketed by Sagent.