FDA OK’s Hikma’s US subsidiary’s narcolepsy drug

Hikma Pharmaceuticals’s US subsidiary Roxane Laboratories has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL for the treatment of cataplexy (sudden loss of muscle strength) and excessive daytime sleepiness in patients with narcolepsy.

Roxane was the first ANDA applicant to submit a substantially complete ANDA with paragraph IV certification for Sodium Oxybate Oral Solution, 500 mg/mL and therefore is eligible for 180 days of generic drug exclusivity following the launch of its product.

Sodium Oxybate Oral Solution is the generic equivalent to Jazz Pharmaceuticals’s Xyrem. In its 2015 Annual Report, Jazz Pharmaceuticals PLC reported net sales of Xyrem of approximately $955 million in 2015.


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