Strides Arcolab has received US FDA approval for midazolam hydrochloride injection (preservative-free) 1 mg/ml and 5 mg/ml single dose vials. Midazolam, a general anaesthetic, will be offered as a sterile, non-pyrogenic parenteral dosage form for intravenous or intramuscular injection. Midazolam is indicated for preoperative use (sedation, anxiolysis, amnesia), prior to or during diagnostic, therapeutic or endoscopic procedures, intravenously for induction of general anaesthesia, and for continuous intravenous infusion for sedation of intubated and mechanically ventilated patients.
As per the IMS data, the total market for midazolam in the USA during 2009 was around US$ 51 million. The market size for the approved strengths of 1mg/ml and 5mg/ml single dose vials which is to be launched in the near future is $31 million. The market size for additional strengths of the multi dose vials, the approval for which is expected shortly, is $18 million.
Midazolam will 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.
Sagent is a privately held specialty pharmaceutical company focused on developing, manufacturing, sourcing and marketing pharmaceutical products, with a specific emphasis on injectable products.