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FDA approves Boca’s carbinoxamine oral solution

The FDA has granted final approval for the Boca Pharmacal's abbreviated new drug application or ANDA to market carbinoxamine maleate oral solution 4mg/5mL to treat seasonal and perennial allergic rhinitis.

Carbinoxamine maleate is a generic version of Pamlab’s Palgic oral solution. The company plans to launch its product immediately.

Robert Edwards Jr., CEO of Boca Pharmacal, said: “Carbinoxamine maleate oral solution is claimed to be the first of many approvals we expect in 2008. Having filed multiple ANDA applications coupled with our multinational partnerships we expect 2008 to be a very big year.”