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APP gets FDA nod for two generic products

APP Pharmaceuticals has received approval from the FDA of its abbreviated new drug applications for bleomycin sulfate for injection, USP, the equivalent of Bristol-Myers Squibb's Blenoxane and caffeine citrate oral solution, USP, 20 mg/ml, the equivalent of Bedford Laboratories's Cafcit Oral Solution.

APP’s bleomycin sulfate is AP-rated, preservative and latex-free, and bar-coded at the individual unit-of-use. It has been shown to be useful in the management of the following neoplasms either as a single agent or in proven combinations with other approved chemotherapeutic agents: squamous cell carcinoma, lymphomas, testicular carcinoma and malignant pleural effusion.
Caffeine citrate oral solution is indicated for the short term treatment of apnea of premature infants.