Lupine gets USFDA nod for two new abbreviated drug applications


The pharmaceutical major announced Friday that it has received approval from the United States Food and Drug Administration (USFDA) for pregabalin and iloperidone tablets.

Pregabalin capsules are used to treat epilepsy and anxiety, while iloperidone tablets are used to treat symptoms of psychotic (mental) disorders, such as schizophrenia.

Pregabalin capsules are marketed as a generic equivalent to Lyrica capsules by Upjohn US 2 LLC. According to IQVIA, pregabalin capsules have an estimated annual sales of $263 million in the United States as of March 2022. The product will be manufactured at the company’s facility in Aurangabad, India.

Iloperidone tablets are on the market a generic equivalent of Fanapt tablets from Vanda Pharmaceuticals. According to IQVIA, iloperidone tablets had estimated annual sales of $162 million in the United States (March 2022). Lupine said the tablets will be manufactured at its factory in Goa, India.

Lupine is a transnational pharmaceutical company. The company develops and markets a wide range of branded and generic formulations, biotechnology products and APIs in more than 100 markets in the United States, India, South Africa and Asia-Pacific (APAC) regions, Latin America (LATAM), Europe and Middle East. .

The company’s consolidated net profit jumped 24.47% to Rs 545.52 crore on a 3.57% increase in total operating income to Rs 4,160.93 crore in Q3 FY22 compared to Q3 FY21 .

Shares of Lupine closed down 0.32% at Rs 723.95 on Friday.

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(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)

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