FDA OKs IMPAX' generic Salagen

IMPAX Laboratories says that the US Food and Drug Administration has granted approval of its Abbreviated New Drug Application for a generic version of Salagen (pilocarpine HCl) 5mg and 7.5mg tablets.

MGI Pharma markets Salagen 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. Total brand and generic sales of the product in the USA were $25 million for 2005, according to Wolters Kluwer Health. Impax said it intends to begin marketing its generic in the near future.