Spectrum receives FDA approval for fluconazole tablets
Saturday, October 01, 2005 14:00 IST Irvine, California
Spectrum Pharmaceuticals Inc. has received an approval from the office of generic drugs of the US Food and Drug Administration for the abbreviated new drug application (ANDA) for fluconazole tablets. Fluconazole is a widely used anti-fungal agent. The branded product, Diflucan, is marketed by Pfizer Pharmaceuticals.
The ANDA for fluconazole is the second oral product filed by NeoJB, LLC, a joint venture between Spectrum and JB Life Science Overseas Ltd, a subsidiary of JB Chemicals & Pharmaceuticals (JBCPL).
According to a company release, this is the third ANDA filed by Spectrum Pharmaceuticals approved by FDA. Currently, nine ANDA’s are pending at the FDA, which among others include ophthalmic drugs, injectable anticancer drugs, and an ANDA with Paragraph IV certification for sumatriptan succinate injection.
