Roxane's generic Keppra cleared in USA
The USA's Roxane Laboratories, a unit of Germany's Boehringer Ingelheim, says that its Abbreviated New Drug Application for levetiracetam tablets, 250mg, 500mg, 750mg, 1,000mg and oral solution 100mg/mL has been approved. The product is available for immediate shipment to wholesalers and pharmacies nationwide.
Roxane's products are the AB-rated generic equivalent to Belgian drugmaker UCB's epilepsy treatment Keppra (levetiracetam). Annual sales of the branded tablets and oral solution are approximately $1.28 billion.
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