- Lannett Company (NYSE:LCI) announces that FDA has approved its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution, 5 mg/5 mL, the therapeutic equivalent to the reference drug, Roxane Laboratories' Diazepam Oral Solution, 5 mg/5 mL.
- According to IMS, the U.S. wholesale market is ~$4M.
- The company says its Diazepam Oral Solution product will be second on the market. Market launch will commence in fiscal Q1 (calendar Q3).