Lannett Says FDA OKs ANDA For Diazepam Oral Solution

(RTTNews) - Lannett Company, Inc. (LCI), a maker of generic pharmaceutical products, said Tuesday that U.S. Food and Drug Administration or FDA has approved its Abbreviated New Drug Application for Diazepam Oral Solution, 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, the company noted.

Arthur Bedrosian, president and CEO of Lannett, said, "We believe our ANDA for Diazepam Oral Solution (Concentrate), 5 mg/mL was the first bioequivalent Diazepam Oral Solution product approved by the FDA." He added, "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."