FDA Approval
Lupin receives US FDA approval for wakefulness drug Modafinil
This story was originally published at 19:59 IST on 4 September 2026
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--US FDA gives approval to Lupin's Modafinil tablets
MUMBAI – Lupin Ltd. Friday said it received approval from the US Food and Drug Administration for its abbreviated new drug application to market generic Modafinil tablets in 100 milligrams and 200 milligrams strength. The US FDA cleared the drug as a bioequivalent alternative to the reference listed drug, Provigil, sold by Nuvo Pharmaceuticals (Ireland) DAC, Lupin said in a press release.
Modafinil is used to improve wakefulness in adults suffering from excessive sleepiness caused by narcolepsy, obstructive sleep apnoea or shift work disorder. Modafinil tablets had estimated annual sales of $70.7 million in the US, according to the press release.
For the June quarter, Lupin reported consolidated net profit of INR 14.15 billion on revenues of INR 82.77 billion. On Friday, the company's shares ended at INR 2,110 on the National Stock Exchange, down 1% from the previous close. End
US$1 = INR 94.49
IST, or Indian Standard Time, is five-and-a-half hours ahead of GMT
Reported by Diksha Singh
Edited by Saji George Titus
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