Strides announces USFDA approval for Lidocaine Hydrochloride Injection

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Announcement Corporate
Last Updated : Jan 21 2013 | 6:57 AM IST

Strides Arcolab Limited (Strides) today announced that it has received USFDA approval for Lidocaine Hydrochloride Injection USP, 0.5% (5 mg/mL), 1% (10 mg/mL), Multi-dose vials.

The Company had earlier announced in October 2010 the following approvals received for Lidocaine:

  • Lidocaine Hydrochloride Injection USP, 20 mg/ML (preservative free), packaged in 100 mg/mL single-use vials.
  • Lidocaine Hydrochloride Injection USP, 0.5% (5mg/mL) & 1% (10mg/mL), packaged in single-use vials.

According to IMS data, the total US market for Lidocaine injection in 2009 was approximated to US$ 61 million.  Strides will be able to address about 50% of the market with the above approvals.  The products are expected to be launched in the near future.

About Lidocaine Hydrochloride Injection
Lidocaine Hydrochloride Injection antiarrhythmic agent (used to treat irregular heartbeat) is administered intravenously by direct injection. The drug may also be used for resistant seizure treatment. It is contraindicated in patients with a known history of hypersensitivity to local aesthetics of the amide type.

About Strides Arcolab Limited:
Strides Arcolab, listed on the Bombay Stock Exchange Limited (532531) and National Stock Exchange of India Limited (STAR), is a global pharmaceutical company headquartered in Bangalore, India that develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectables.

The company has 14 manufacturing facilities across 6 countries with presence in more than 75 countries in developed and emerging markets. Manufacturing is ably supported by a 350-scientist strong global R&D Centre located in Bangalore.

Additional information is available at the company’s website at www.stridesarco.com.

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First Published: Dec 10 2010 | 6:34 PM IST

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