FDC Ltd has received USFDA approval for its ANDA of Fluconazole tablets, a generic version of Pfizer’s Diflucan. The antifungal drug, with U.S. sales of $43 million annually, will boost FDC’s presence in the American generics market and expand its anti-infective portfolio.
FDC Limited has achieved a significant milestone with the United States Food and Drug Administration (USFDA) granting final approval for its Abbreviated New Drug Application (ANDA) for Fluconazole tablets. This approval allows FDC to market its generic version of Pfizer’s well-known antifungal drug, Diflucan, in the U.S.
Key Highlights
-
Regulatory Win: The ANDA approval strengthens FDC’s footprint in the U.S. generics market, a critical growth driver for Indian pharmaceutical companies.
-
Therapeutic Use: Fluconazole is widely prescribed to treat fungal and yeast infections, including candidiasis and cryptococcal meningitis.
-
Market Potential: According to IQVIA data, Fluconazole tablets generated annual U.S. sales of approximately $43 million (as of July 2023), underscoring the commercial opportunity for FDC.
-
Strategic Impact: This approval enhances FDC’s portfolio of anti-infective therapies and positions the company to capture market share in a competitive segment.
This development reflects the growing strength of Indian pharma firms in delivering affordable, high-quality generics to global markets, while also expanding patient access to essential medicines.
Sources: USFDA, Moneycontrol, Mondaq