FDAnews

IMPAX GETS FDA APPROVAL FOR GENERIC VERSION OF SALAGEN

Impax Laboratories has announced that the FDA has granted approval of the company's abbreviated new drug application (ANDA) for a generic version of Salagen (pilocarpine hydrochlorine) 5 mg and 7.5 mg tablets.

MGI Pharma markets Salagen tablets for the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and for the treatment of symptoms of dry mouth in patients with Sjogren's Syndrome.