Roxane Launches Ropinirole Hydrochloride Tablets

Armen Hareyan's picture
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Roxane Laboratories announced the approval of its ANDA for Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg by FDA. The product is available in Bottles of 100 and is available for immediate shipment to wholesalers and pharmacies nationwide.

Roxane Laboratories' Ropinirole Hydrochloride Tablets are AB rated to REQUIP (ropinirole hydrochloride) Tablets. Annual sales of Ropinirole Hydrochloride Tablets, 0.25mg, 0.5mg, 1mg, 2mg, 3mg, 4mg, 5mg are approximately $499 Million(1).

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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.

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