COLUMBUS, Ohio, Jan. 26 Roxane Laboratories, Inc. announced today the New Drug Application (NDA) approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL bottles as of January 25th, 2010 by the Food and Drug Administration. This product is indicated for the relief of moderate to severe acute and chronic pain where use of an opioid analgesic is appropriate.
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Roxane Laboratories', Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) is the only FDA approved Morphine Sulfate Oral Solution CII available at this concentration. Roxane Laboratories, Inc. has sufficient supply to meet the entire market demand and no shortage is anticipated. Roxane Laboratories, Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL), will be transitioning to new packaging, labeling, and NDC numbers in the near future. In the mean time, please continue to use the following Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) NDC numbers:
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NDC 0054-0352-44 Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL Bottle
NDC 0054-0352-50 Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 120mL Bottle
Roxane Laboratories, Inc. Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL) 30mL and 120mL is available for immediate shipment to wholesalers and pharmacies nationwide.
Full prescribing information for Morphine Sulfate Oral Solution CII is available on the Roxane Laboratories website at www.Roxane.com or upon request by calling Roxane Laboratories Technical Product Information at 1.800.962.8364.
About Roxane Laboratories, Inc.
Roxane Laboratories, Inc. is located in Columbus, OH in a modern 500,000 square foot manufacturing and laboratory facility. The facility spans 70 acres and currently employs over 1,000 people. Currently, Roxane Laboratories, Inc. markets more than 75 medications in nearly 250 package sizes, focusing on an expanding line of Multisource pharmaceutical products including: bulk and unit-dose liquids and solids; coated, sustained-release and controlled-release tablets; nasal sprays, cytotoxics and CII narcotics.
Roxane Laboratories, Inc., is a subsidiary of Boehringer Ingelheim Corporation, based in Ridgefield, CT and a member of the Boehringer Ingelheim group of companies.
About Boehringer Ingelheim
Boehringer Ingelheim Corporation based in Ridgefield, CT, is the US headquarters to seven subsidiaries and a member of the Boehringer Ingelheim group of companies.
The Boehringer Ingelheim group is one of the world's 20 leading pharmaceutical companies. Headquartered in Ingelheim, Germany, it operates globally with 138 affiliates in 47 countries and approximately 41,300 employees. Since it was founded in 1885, the family-owned company has been committed to researching, developing, manufacturing and marketing novel products of high therapeutic value for human and veterinary medicine.
In 2008, Boehringer Ingelheim posted net sales of US $17.0 billion (euro 11.6 billion) while spending approximately one-fifth of net sales in its largest business segment, Prescription Medicines, on research and development.
For more information on Boehringer Ingelheim, please visit http://us.boehringer-ingelheim.com.
SOURCE Roxane Laboratories, Inc.
