Navigation Links
Roxane Laboratories, Inc. Announces the New Drug Application Approval of Morphine Sulfate Oral Solution CII, 100mg/5mL (20mg/mL)
Date:1/26/2010

COLUMBUS, Ohio, Jan. 26 /PRNewswire/ -- 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.

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:

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.

RELATED LINKS
http://www.Roxane.com

'/>"/>

SOURCE Roxane Laboratories, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Roxane Laboratories, Inc. Announces the Launch of Oxcarbazepine Tablets, 150mg, 300mg and 600mg
2. Roxane Laboratories, Inc. Announces the Launch of Balsalazide Disodium Capsules, 750mg
3. Roxane Laboratories, Inc. Announces the Launch of Granisetron Hydrochloride Tablets, 1mg
4. Roxane Laboratories, Inc. Announces the Launch of Acarbose Tablets
5. Roxane Laboratories, Inc. Announces the Launch of Ramipril Capsules
6. Roxane Laboratories, Inc. Announces the Approval of Morphine Sulfate Tablets and Oral Solution
7. Roxane Laboratories, Inc. Initiates a Nationwide Voluntary Recall of Two Manufacturing Lots of Sodium Polystyrene Sulfonate Suspension in the US and Puerto Rico
8. Roxane Laboratories, Inc. Announces the Launch of Levetiracetam Tablets and Oral Solution
9. Roxane Laboratories, Inc. Announces the Launch of Risperidone Oral Solution 1mg/mL
10. Roxane Laboratories, Inc. Announces the Launch of Perindopril Erbumine Tablets
11. Caraco Pharmaceutical Laboratories, Ltd. Announces FDA Approval to Market Generic Version of Zyloprim(R)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2017)... ... July 24, 2017 , ... Peruvian Ayahuasca retreat, ... be awarded annually to and divided between two full-time university students enrolled in ... Amazonian plant medicine. To apply for the scholarship, students are asked to submit ...
(Date:7/24/2017)... ... 24, 2017 , ... The Topricin Companies, formerly Topical Biomedics, ... revolutionary, natural, after-burn skin care product, Topricin After Burn Cream. , ... skin conditions, including cancer. In the short term, overexposure to sun, wind ...
(Date:7/24/2017)... Switzerland (PRWEB) , ... July 24, 2017 , ... Anyone ... to weigh a watermelon, nor would a pharmacist using that same scale to dispense ... risk someone’s health. , These illustrations show why it is important to have ...
(Date:7/24/2017)... ... 2017 , ... Paul Vitenas, MD, FACS is excited to report that he ... attend Allergan’s recent meeting with their Plastics Advisory Board. As one of the top ... bringing a newly defined structure to the aesthetics market. Dr. Vitenas , along ...
(Date:7/24/2017)... ... ... Summer storms are inevitable as weather temperatures in Philadelphia climb. These ... tree damage requiring emergency tree service. Giroud Tree and Lawn provides ... hazardous tree removal. , “A summer storm is like a bully on ...
Breaking Medicine News(10 mins):
(Date:7/14/2017)... plc (NASDAQ: ENDP ) will announce its second-quarter 2017 ... management team will host a conference call and webcast before the ... The dial-in number to access the call is U.S./ Canada ... 45397076. Please dial in 10 minutes prior to the scheduled start ... the call will be available from August 8, 2017 at 11:30 ...
(Date:7/13/2017)...  Centurion Medical Products, a leader in medical product innovation and ... removal device for hospice patient care. ... Centurion Medical Products ... Patient pain management and emotional comfort are part of a ... pain while preventing unneeded emergency department admission due to severe fecal ...
(Date:7/13/2017)... Md. , July 13, 2017  New York City-based ... of pharmaceutical markets should be aware of.  From new products ... trends are detailed in a recently completed study, Potential ... 1.  Age-Driven Growth ... we have been aware of the impact the growing population ...
Breaking Medicine Technology: