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news.Boca Pharmacal has announced that the FDA has granted final approval for the company's abbreviated new drug application to market its generic version of Pamlab's Palgic 4mg tablet.
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Carbinoxamine Maleate 4mg tablet is indicated to treat seasonal and perennial allergic rhinitis, vasomotor rhinitis, allergic conjunctivitis due to inhalant allergens and food, mild, uncomplicated allergic skin manifestations of urticaria and angioedema.
It is also indicated as therapy for anaphylactic reactions adjunctive to epinephrine and other standard measures after acute manifestations have been controlled and amelioration of the severity of allergic reactions to blood or plasma.
Robert Edwards, Jr, CEO of Boca, said: “Carbinoxamine Maleate 4mg tablet is one more approval stemming from strong R&D and a robust product pipeline. We are pleased with our success and look forward to more filings and approvals this year.”