FDA approves Lannett's ANDA for Diazepam Oral Solution

Lannett Company, Inc. (NYSE:LCI) today announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution (Concentrate), 5 mg/mL, a Schedule C-IV controlled drug. Diazepam Oral Solution (Concentrate), 5 mg/mL, is therapeutically equivalent to the reference listed drug, Diazepam Intensol Oral Solution (Concentrate), 5 mg/mL, of Roxane Laboratories, Inc.

"We believe our ANDA for Diazepam Oral Solution (Concentrate), 5 mg/mL was the first bioequivalent Diazepam Oral Solution product approved by the FDA," said Arthur P. Bedrosian, president and chief executive officer of Lannett. "We continue to develop and file applications for controlled substances. Currently, we have 16 product applications pending at FDA and another 55 products in various stages of development."