US FDA Approves Lupin’s Valbenazine Capsules


As the pharmaceutical giant received approval for valbenazine capsules from the US Food and Drug Administration (FDA), its shares soared by more than 5% on Friday. Adults with tardive dyskinesia, a medical condition that affects movement and facial tics like lip-smacking and grimacing, are treated with this medication.

According to Lupin, the US FDA FDA has tentatively approved its Abbreviated New Drug Application (ANDA), Valbenazine Capsules, 40 mg, 60 mg, and 80 mg, to market a generic version of Neurocrine Biosciences, Inc.’s Ingrezza Capsules, 40 mg, 60 mg, and 80 mg. The sales of valbenazine capsules in the United States were estimated to total $1,235 million.

After rising as much as 5.3% to Rs 673.6 per share during the session, Lupin shares ended the day with a gain of Rs 19.4%, or 3%, at Rs 659.1 per share on the BSE. In the past year, the Nifty Pharma index has decreased by 12%, while the Lupin stock has lost 11%.

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Nilesh Gupta, the managing director of Lupin, said that they are proud that their Pithampur site has been successfully inspected again by the MHRA, highlighting their unwavering commitment to quality and compliance. This is a significant facility that must uphold the highest quality and compliance standards due to the combination of oral solid, inhalation, dermatology, and oral contraceptive products.