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FDA Approves Bedford Labs 100 mg/50 mL Fluconazole Injection

By Pharmaceutical Processing | January 14, 2010

Bedford Laboratories, adivision of Ben Venue Laboratories, Inc., is pleased to announce FDA approvalfor the addition of 100 mg/50 mL Fluconazole Injection to its existingFluconazole Injection line. This product is AP rated and is equivalent toDiflucan@ by Pfizer. Fluconazole Injection is an antifungal agent indicatedfor oropharyngeal and esophageal candidiasis, cryptococcal meningitis, and isindicated for the prophylaxis of candidiasis. “Pharmacists asked, we answered. In our continuing effort to offer themost comprehensive and cost effective line of injectables in the multisourceindustry, Bedford Laboratories is pleased to be the first to offer this uniquedosage. Fluconazole Injection 100 mg/50 mL is right-sized for smaller doses,speeding productivity and saving time. This continues to demonstrate ourcommitment to providing a broad-based portfolio of products,” said DavidGaugh, Vice President of Bedford Laboratories. Bedford Laboratories will supply Fluconazole Injection sterile iso-osmoticsolution containing 2 mg/mL of fluconazole in glass vials in the followingpresentations: Vials containing either 100 mg, 200 mg or 400 mg equivalent offluconazole. In addition, Bedford Laboratories will supply FluconazoleInjection as a sterile iso-osmotic solution containing 2 mg / mL offluconazole in 0.9% sodium chloride diluent in the following presentations:200 mg/100 mL in single-dose PVC flexible containers packaged in cartonscontaining 10 bags and 400 mg/200 mL in single-dose PVC flexible containerspackaged in cartons containing 10 bags.

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