COLUMBUS, Ohio, May 5 /PRNewswire/ -- Roxane Laboratories, Inc. announced today the approval of its Abbreviated New Drug Application (ANDA) for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by the U.S. Food and Drug Administration. The product is available in Bottles of 100 and is available for immediate shipment to wholesalers and pharmacies nationwide.
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Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated to REQUIP(R) (ropinirole hydrochloride) Tablets. Annual sales of Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg are approximately $499 Million(1).
Roxane Laboratories' Ropinirole Hydrochloride Tablets are indicated for the treatment of moderate-to-severe primary Restless Leg Syndrome (RLS).
The most commonly reported side effects in people taking ropinirole for RLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You should be careful until you know if ropinirole affects your ability to remain alert while doing normal daily activities, and you should watch for the development of significant daytime sleepiness or episodes of falling asleep. It is possible that you could fall asleep while doing normal activities such as driving a car, doing physical tasks, or using hazardous machinery while taking ropinirole. Your chances of falling asleep while doing normal daily activities while taking ropinirole are greater if you are taking other medicines that cause drowsiness. Hallucinations (unreal sounds, visions, or sensations) have also been reported in patients taking ropinirole, however, this was uncommon in patients taking ropinirole for RLS.
This is not a complete list of side effects and should not take the place of discussions with your healthcare providers.
Full prescribing information for Ropinirole Hydrochloride Tablets 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 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 markets over 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 135 affiliates in 47 countries and approximately 39,800 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 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9 billion euro) 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.
(1) IMS MAT dollar sales ending 01/2008
REQUIP(R) is a registered trademark of GlaxoSmithKline
CONTACT: Jason Kurtz for Roxane Laboratories, +1-440-201-3668,
jason.kurtz@boehringer-ingelheim.com
Web site: http://www.Roxane.com/
http://us.boehringer-ingelheim.com/
