Bedford Laboratories®16 April 2014
February 16, 2010

Bedford Laboratories First to Manufacture FDA Approved Indomethacin for Injection USP

Bedford Laboratories™, a division of Ben Venue Laboratories, Inc., a provider of select specialty injectables, is pleased to announce the addition of Indomethacin for Injection to its existing product line. This product is AP rated and is equivalent to Indocin® by Lundbeck Inc. Indomethacin for Injection is indicated to close a hemodynamically significant patent ductus arteriosus in premature infants weighing between 500 and 1750 g when after 48 hours usual medical management (e.g., fluid restriction, diuretics, digitalis, respiratory support, etc.) is ineffective. Clear-cut clinical evidence of a hemodynamically significant patent ductus arteriosus should be present, such as respiratory distress, a continuous murmur, a hyperactive precordium, cardiomegaly and pulmonary plethora on chest x-ray.

Bedford Laboratories will supply Indomethacin for Injection USP as single dose vials containing indomethacin sodium, equivalent to 1 mg indomethacin. "We are all very excited and pleased to announce the launch of this critical product. The release of this product to the market place is very timely, given that the innovator product is currently on long-term backorder (source: www.fda.gov). This is a great milestone for Bedford Laboratories and we are very proud to add this product to our growing portfolio," said David Gaugh, Vice President and General Manager, Bedford Laboratories.

Prescribing information is available upon request from the Bedford Laboratories’ professional services department at 800.521.5169, or from the company’s web site, www.bedfordlabs.com.  

Indocin® is a registered trademark of Lundbeck, Inc.

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