Lupin gets USFDA nod to market anti-fungal capsules
New Delhi: Drug firm Lupin has received nod from the US health regulator to market its Flucytosine capsules used for treatment of fungal infections.
The company has received final approval to market its Flucytosine capsules USP, in the strengths of 250 mg and 500 mg, from the United States Food and Drug Administration (USFDA), Lupin said in a statement.
The product is generic version of Valeant Pharmaceuticals International Inc’s Ancobon capsules in the same strengths, it added.
The capsules are indicated for the treatment of serious infections caused by susceptible strains of Candida and/or Cryptococcus, Lupin said.
As per IMS MAT March 2017 data, Ancobon capsules had US sales of $46.6 million, it added.
The company’s cumulative filings with the USFDA now stand at 368. It has received approvals for 218 products while 150 product filings are pending approval.
Shares of Lupin Ltd were on Monday trading at Rs1,152.75 per scrip in the afternoon trade on BSE, up 3.22% from its previous close.