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Lupin receives approval from USFDA for Vigabatrin for Oral Solution USP

14 Mar 2022 , 01:20 PM

Global pharma major Lupin Limited (Lupin) on Friday announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), Vigabatrin for Oral Solution USP, 500 mg to market a generic equivalent of Sabril for Oral Solution, 500 mg of Lundbeck Pharmaceuticals, LLC.

The product will be manufactured at Lupin’s facility in Goa, India. Vigabatrin for Oral Solution USP, 500 mg (RLD Sabril) had estimated annual sales of USD 275 million in the U.S. (IQVIA MAT December 2021).

At around 1.22 pm, Lupin Ltd was trading at Rs744.75 per piece down by Rs3.4 or 0.45% from its previous closing of Rs748.15 per piece on the BSE.

Related Tags

  • Goa Facility
  • Lupin Limited
  • Lupin News
  • Lupin share price
  • Lupin stock price
  • Oral Solution USP
  • USFDA
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