Lannett's pilocarpine ANDA cleared by FDA

Lannett, a US manufacturer of generic pharmaceuticals, says it has received approval from the Food and Drug Administration of its  supplemental Abbreviated New Drug Application for pilocarpine tablets,  7.5mg, the generic equivalent of Salagen, marketed by Eisai  Pharmaceuticals. Lannett previously received and currently markets  pilocarpine tablets, in the 5mg strength. According to Wolters Kluwer,  sales in 2008 of both generic and brand pilocarpine 7.5mg tablets were  $2.5 million at Average Wholesale Price.

Pilocarpine is indicated for the treatment of symptoms of dry mouth from  salivary gland hypofunction caused by radiotherapy for cancer of the  head and neck and in patients with Sjogren's syndrome.

"This approval adds an important dosage strength to our pilocarpine  product offering," said Arthur Bedrosian, chief executive of Lannett.  "We are now able to offer our customers one -top shopping for both  strengths," he added.