Multinational London-based pharmaceutical group Hikma Pharmaceuticals PLC’s wholly owned US subsidiary Roxane Laboratories Inc has received an approval from the US Food and Drug Administration (FDA) for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem by Jazz Pharmaceuticals.
Roxane’s Sodium Oxybate Oral Solution is indicated for the treatment of cataplexy (sudden loss of muscle strength) and excessive daytime sleepiness in patients with narcolepsy.
Roxane is currently involved in patent litigation concerning this product in the US District Court for the District of New Jersey.
Roxane was the first ANDA [Abbreviated New Drug Application] 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.
On its Drug Safety and Availability website, the FDA states:
Because of the potential risks associated with Xyrem, it is subject to strict safety controls on prescribing and dispensing under a program called a Risk Evaluation and Mitigation Strategy (REMS). FDA’s approval of generic sodium oxybate is subject to a REMS with strict safety controls that are comparable to those currently required for Xyrem.
Specifically, under both the Xyrem REMS and the generic sodium oxybate REMS, sodium oxybate can be prescribed only by a certified prescriber, and dispensed only to an enrolled patient by a certified pharmacy. Only a certified pharmacy that ships directly to patients can dispense sodium oxybate. Sodium oxybate will not be available in retail pharmacies.
In approving this generic version of Xyrem, the FDA is maintaining strict safety requirements for sodium oxybate, while providing patients with access to a generic medication option for narcolepsy.