Lupin Gets US FDA Approval for Modafinil Tablets

Global pharmaceutical major Lupin Limited has received approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Modafinil Tablets USP, 100 mg and 200 mg. The approved tablets are bioequivalent to Provigil® Tablets and are indicated for improving wakefulness in adult patients with narcolepsy, obstructive sleep apnea (OSA), or shift work disorder (SWD). The U.S. market for Modafinil Tablets had estimated annual sales of USD 70.7 million as of July 2026.