Lannett announced that the Food and Drug Administration (FDA) has approved its Abbreviated New Drug Application (ANDA) for Diazepam Oral Solution, the therapeutic equivalent to Roxane‘s reference listed product.
Diazepam Oral Solution, a benzodiazepine, is indicated to treat anxiety, as adjunct for skeletal muscle spasm, and as adjunct in convulsive disorders. It appears to act on parts of the limbic system, the thalamus and hypothalamus, and induces calming effects. Diazepam has no demonstrable peripheral autonomic blocking action nor does it produce extrapyramidal side effects.
Lannett’s Diazepam Oral Solution, a CIV controlled substance, will be available as a 5mg/5mL strength in July 2016.
For more information visit Lannett.com.