Lannett Company has announced that its wholly owned subsidiary, Silarx Pharmaceuticals, Inc., has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Memantine Hydrochloride Oral Solution 2 mg/mL, the therapeutic equivalent to the reference listed drug Namenda® Oral Solution, 2 mg/mL of Forest Pharmaceuticals. According to IMS, for the year ended June 2015 total sales of Memantine Hydrochloride Oral Solution 2 mg/mL at Average Wholesale Price (AWP) were approximately $12 million.
"Memantine Hydrochloride Oral Solution 2 mg/mL is an important product used to treat dementia associated with Alzheimer's disease," said Arthur Bedrosian, chief executive officer of Lannett. "This product expands our portfolio of generic drugs in liquid dosage form and represents the second approval received from our recently completed acquisition of Silarx. We expect to commence marketing immediately."