Lannett Company Inc, a manufacturer of generic pharmaceuticals, has received approval from the US Food and Drug Administration (FDA) for its supplemental Abbreviated New Drug Application (ANDAs) for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen, marketed by Eisai Pharmaceuticals. Lannett previously received and currently markets Pilocarpine HCI tablets, in the 5 mg strength.
According to Wolters Kluwer, sales in 2008 of both generic and brand Pilocarpine HCI 7.5 mg tablets were $2.5 million at average wholesale price. Pilocarpine HCI tablets are indicated for the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and the treatment of symptoms of dry mouth in patients with Sjogren's syndrome.
"This approval adds an important dosage strength to our Pilocarpine product offering," said Arthur Bedrosian, president and chief executive officer of Lannett. "We are now able to offer our customers one stop shopping for both strengths."
Lannett Company, founded in 1942, develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications.