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Zyrtec-D Switch Approved – J&J Will Launch Behind The Counter This Year

This article was originally published in The Tan Sheet

Executive Summary

FDA approved Johnson & Johnson's bid to switch prescription antihistamine/nasal decongestant Zyrtec-D to nonprescription status, but the firm is still awaiting a reply on single-ingredient Zyrtec

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FDA grants final approval for McNeil Consumer Healthcare's generic Zyrtec to nine firms, the agency announces Dec. 27. Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan Pharmaceuticals, Par Pharmaceutical Companies, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt will offer the cetirizine HCl allergy and hives treatment in 5 mg and 10 mg tablets. FDA approved prescription-strength Zyrtec for over-the-counter sale Nov. 16, one week after approving McNeil's switch application for its Zyrtec-D allergy treatment decongestant combination product (1"The Tan Sheet" Nov. 12, 2007, p. 9). OTC Zyrtec is expected to be available for retail sale in late January...

Generic Zyrtec

FDA grants final approval for McNeil Consumer Healthcare's generic Zyrtec to nine firms, the agency announces Dec. 27. Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan Pharmaceuticals, Par Pharmaceutical Companies, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt will offer the cetirizine HCl allergy and hives treatment in 5 mg and 10 mg tablets. FDA approved prescription-strength Zyrtec for over-the-counter sale Nov. 16, one week after approving McNeil's switch application for its Zyrtec-D allergy treatment decongestant combination product (1"The Tan Sheet" Nov. 12, 2007, p. 9). OTC Zyrtec is expected to be available for retail sale in late January...

Generic Zyrtec

FDA grants final approval for McNeil Consumer Healthcare's generic Zyrtec to nine firms, the agency announces Dec. 27. Actavis, Apotex, Caraco Pharmaceutical Laboratories, Mylan Pharmaceuticals, Par Pharmaceutical Companies, Perrigo, Ranbaxy Laboratories, Sandoz and Wockhardt will offer the cetirizine HCl allergy and hives treatment in 5 mg and 10 mg tablets. FDA approved prescription-strength Zyrtec for over-the-counter sale Nov. 16, one week after approving McNeil's switch application for its Zyrtec-D allergy treatment decongestant combination product (1"The Tan Sheet" Nov. 12, 2007, p. 9). OTC Zyrtec is expected to be available for retail sale in late January...

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