Lupin Gets FDA Approval For Modafinil Tablets

(RTTNews) - Lupin Limited (500257) announced that it has received U.S. Food and Drug Administration approval for its Abbreviated New Drug Application for Modafinil Tablets USP, 100 mg and 200 mg.

The approved tablets are bioequivalent to the reference listed drug, Provigil Tablets of Nuvo Pharmaceuticals (Ireland) DAC. Modafinil is indicated to improve wakefulness in adults with excessive sleepiness associated with narcolepsy, obstructive sleep apnea or shift work disorder.

According to IQVIA MAT July 2026 data cited by Lupin, Modafinil Tablets, with Provigil as the reference drug, had estimated annual U.S. sales of $70.7 million.

The latest approval expands Lupin's portfolio of products approved for the U.S. market.