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Roxane Laboratories, Inc. Announces the Launch of Ropinirole Hydrochloride Tablets

Tuesday, May 6, 2008 General News
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COLUMBUS, Ohio, May 5 Roxane Laboratories, Inc. announcedtoday the approval of its Abbreviated New Drug Application (ANDA) forRopinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg bythe U.S. Food and Drug Administration. The product is available in Bottles of100 and is available for immediate shipment to wholesalers and pharmaciesnationwide.
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(Logo: http://www.newscom.com/cgi-bin/prnh/20070410/CLTU122LOGO )

Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated toREQUIP(R) (ropinirole hydrochloride) Tablets. Annual sales of RopiniroleHydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg areapproximately $499 Million(1).
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Roxane Laboratories' Ropinirole Hydrochloride Tablets are indicated forthe treatment of moderate-to-severe primary Restless Leg Syndrome (RLS).

The most commonly reported side effects in people taking ropinirole forRLS are nausea, vomiting, dizziness, and drowsiness or sleepiness. You shouldbe careful until you know if ropinirole affects your ability to remain alertwhile doing normal daily activities, and you should watch for the developmentof significant daytime sleepiness or episodes of falling asleep. It ispossible that you could fall asleep while doing normal activities such asdriving a car, doing physical tasks, or using hazardous machinery while takingropinirole. Your chances of falling asleep while doing normal daily activitieswhile taking ropinirole are greater if you are taking other medicines thatcause drowsiness. Hallucinations (unreal sounds, visions, or sensations) havealso been reported in patients taking ropinirole, however, this was uncommonin patients taking ropinirole for RLS.

This is not a complete list of side effects and should not take the placeof discussions with your healthcare providers.

Full prescribing information for Ropinirole Hydrochloride Tablets isavailable on the Roxane Laboratories website at www.Roxane.com or upon requestby calling Roxane Laboratories Technical Product Information at1.800.962.8364.

About Roxane Laboratories, Inc.

Roxane Laboratories is located in Columbus, OH in a modern 500,000 squarefoot manufacturing and laboratory facility. The facility spans 70 acres andcurrently employs over 1,000 people. Currently, Roxane Laboratories marketsover 75 medications in nearly 250 package sizes, focusing on an expanding lineof Multisource pharmaceutical products including: bulk and unit-dose liquidsand solids; coated, sustained-release and controlled-release tablets; nasalsprays, cytotoxics and CII narcotics.

Roxane Laboratories, Inc., is a subsidiary of Boehringer IngelheimCorporation, based in Ridgefield, CT and a member of the Boehringer Ingelheimgroup of companies.

About Boehringer Ingelheim

Boehringer Ingelheim Corporation based in Ridgefield, CT, is the USheadquarters to seven subsidiaries and a member of the Boehringer Ingelheimgroup of companies.

The Boehringer Ingelheim group is one of the world's 20 leadingpharmaceutical companies. Headquartered in Ingelheim, Germany, it operatesglobally with 135 affiliates in 47 countries and approximately 39,800employees. Since it was founded in 1885, the family-owned company has beencommitted to researching, developing, manufacturing and marketing novelproducts of high therapeutic value for human and veterinary medicine.In 2007, Boehringer Ingelheim posted net sales of US $15.0 billion (10.9billion euro) while spending approximately one-fifth of net sales in itslargest business segment, Prescription Medicines, on research and development.

For more information on Boehringer Ingelheim, please visithttp://us.boehringer-ingelheim.com.

(1) IMS MAT dollar sales ending 01/2008

REQUIP(R) is a registered trademark of GlaxoSmithKline

SOURCE Roxane Laboratories, Inc.
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