Generic Nuvigil Abbreviated New Drug Application Gets FDA Nod

Breckenridge Pharmaceutical, Inc. has announced that its Abbreviated New Drug Application (ANDA) for armodafinil tablets has received final approval from the FDA. The tablets, which are being created in 50-mg, 150-mg and 250-mg doses, are generic versions of Nuvigil from Cephalon, the subsidiary of Teva Pharmaceutical Industries.

The 2 companies have entered into a confidential settlement, which includes a license to market the ANDA 180 days after the initial launch of the generic Nuvigil tablets. Breckenridge will launch the drug with its partner, Natco Pharma Limited.

Armodafinil is designed to improve wakefulness in adult patients with excessive sleepiness due to obstructive sleep apnea, narcolepsy, or shift work disorder. The most commonly reported adverse event associated with the drug is headache. However, some patients may also experience insomnia, nausea, skin rash, anxiety, and xerostomia.

Less common adverse events include blistering, burning, difficulty breathing, fever, and shakiness in the legs, arms, hands, and feet.

Armodafinil has not been studied in pediatric patients, and it is therefore not approved for use in young individuals.

The safety and efficacy of armodafinil, has been studied in clinical trials. It is not indicated as a cure for narcolepsy, obstructive sleep apnea, or shift work disorder, but rather an option for more wakefulness.