| 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. |
| |
|
| |
Content Guide
