JB Chem receives US FDA nod for fluconazole tablets

J B Chemicals & Pharmaceuticals said on Thursday that it had received an approval from the US Food and Drug Administration to manufacture and market its antifungal drug fluconazole in the US market.

Fluconazole is generally indicated towards treatment of vaginal candidiasis, oropharyngeal and oesophageal candidiasis, cryptococcal meningitis.

The drug is also used in prophylactic treatment of patients who have undergone bone marrow transplantation, to decrease incidences of candidiasis.

The company informed the Bombay Stock Exchange that the market size of the drug was $610 million in the US. The company's ciprofloxacin tablets 250 mg, 500 mg, 750 mg have already been approved by the USFDA.

In order to tap the generic market, the company plans to file more Abbreviated New Drug Applications (ANDAs) in the coming years.

"We all, at JBCPL are extremely excited, as this approval will further strengthen our expanding product portfolio in the US, which is the largest pharmaceutical market in the world offering great opportunity," said J B Mody, the company's chairman and managing director.