FDA Approves Carbinoxamine Maleate Tablet
Boca Pharmacal announced that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Pamlab's Palgic 4mg Tablet (Carbinoxamine Maleate 4 mg Tablet). The Company plans to launch its product immediately.
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, dermatographism, 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.
"In a world of rising healthcare costs we pride ourselves on our ability to offer lower volume items that may have been overlooked by the generic pharma giants," commented Robert J. Edwards Jr., CEO. "This is another example of our continuing effort to provide affordable prescription drugs. 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."