Bedford Laboratories, a division of Ben Venue Laboratories, Inc., announced the US FDA approval for the addition of 100 mg/50 mL Fluconazole injection to its existing Fluconazole injection line. This product is AP rated and is equivalent to Diflucan by Pfizer. Fluconazole injection is an antifungal agent indicated for oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and is indicated for the prophylaxis of candidiasis.
"Pharmacists asked, we answered. In our continuing effort to offer the most comprehensive and cost effective line of injectables in the multisource industry, Bedford Laboratories is pleased to be the first to offer this unique dosage. Fluconazole injection 100 mg/50 mL is right-sized for smaller doses, speeding productivity and saving time. This continues to demonstrate our commitment to providing a broad-based portfolio of products," said David Gaugh, vice president of Bedford Laboratories.
Bedford Laboratories will supply Fluconazole Injection sterile iso-osmotic solution containing 2 mg/mL of fluconazole in glass vials in the following presentations: Vials containing either 100 mg, 200 mg, or 400 mg equivalent of fluconazole. In addition, Bedford Laboratories will supply Fluconazole Injection as a sterile isosmotic solution containing 2 mg/mL of fluconazole in 0.9 per cent sodium chloride diluent in the following presentations: 200 mg/100 mL in single-dose PVC flexible containers packaged in cartons containing 10 bags and 400 mg/200 mL in single-dose PVC flexible containers packaged in cartons containing 10 bags.