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news.Bedford Laboratories (Bedford) has received FDA approval for the addition of 100mg/50ml Fluconazole injection to its existing Fluconazole injection line. The 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.
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Bedford is expected to supply Fluconazole injection sterile iso-osmotic solution containing 2mg/ml of fluconazole in glass vials in the following presentations: Vials containing either 100mg, 200mg or 400mg equivalent of fluconazole.
In addition, Bedford will supply Fluconazole injection as a sterile iso-osmotic solution containing 2mg / ml of fluconazole in 0.9% sodium chloride diluent in the following presentations: 200mg/100ml 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.
David Gaugh, vice president of Bedford, said: “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/50ml 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.”