Lannett Company Receives FDA Approval For Pilocarpine HCI Tablets 7.5 Mg Strength

Main Category: Cancer / Oncology
Also Included In: Regulatory Affairs / Drug Approvals
Article Date: 11 May 2009 - 4:00 PDT

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Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of 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 1) the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck; and 2) 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."

Source
Lannett Company

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