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Perrigo, Sandoz get Zyrtec-D generic approval

This article was originally published in The Tan Sheet

Executive Summary

Allegan, Mich.-based Perrigo's development partner, Teva Pharmaceutical Industries, along with Novartis subsidiary Sandoz separately received final FDA approval for Abbreviated New Drug Applications for private-label versions of McNeil Consumer Healthcare's Zyrtec-D extended-release tablets, according to FDA. The OTC cetirizine 5 mg/pseudoephedrine 120 mg extended-release tablets carry an indication for 12-hour relief of indoor and outdoor allergy symptoms and nasal congestion, Perrigo says in a March 6 release. FDA approved Zyrtec and Zyrtec-D for OTC use in November, and Perrigo wasted no time in launching its Zyrtec equivalent in January, ahead of the branded product (1"The Tan Sheet" Nov. 19, 2007, In Brief and 2"The Tan Sheet" Feb. 11, 2008, p. 9). The firm says it anticipates shipping the product in the next 90 days...

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Perrigo gets FDA OK for children’s cetirizine

Allegan, Mich.-based Perrigo receives FDA approval for its children's cetirizine hydrochloride oral solution (allergy) and children's cetirizine hydrochloride oral solution (hives-relief), 1 mg/mL, preparations, according to a letter from the agency April 9. The products are equivalent to McNeil Consumer Healthcare's Children's Zyrtec Oral Solution (Allergy) Children's Zyrtec Oral Solution (Hives-Relief), the agency states. Perrigo filed Abbreviated New Drug Applications for the children's versions of the allergy medication in December, according to the letter. Perrigo already markets a private-label equivalent to the adult-indicated Zyrtec (cetirizine 5 mg) and received approval for a generic version of Zyrtec-D extended-release tablets (cetirizine 5 mg/pseudoephedrine 120 mg) March 6 (1"The Tan Sheet" March 10, 2008, In Brief). FDA approved both Zyrtec products for OTC use in November, and Perrigo was first to launch its Zyrtec equivalent in January, ahead of the branded product ("2The Tan Sheet" Nov. 19, 2007, In Brief and "3The Tan Sheet" Feb. 11, 2008, p. 9)...

Perrigo Fuels “Growth Engine” With Spending On New Product Pipeline

Perrigo plans to file more than 10 abbreviated new drug applications before July this year, President and CEO Joe Papa said Feb. 5

FDA approves Zyrtec OTC

The agency approves Zyrtec (cetirizine HCl) for nonprescription use, one week after it granted McNeil Consumer Healthcare, a subsidiary of Johnson & Johnson, approval to switch the allergy treatment's decongestant combination product, Zyrtec-D (1"The Tan Sheet" Nov. 12, 2007, p. 9). The prescription-strength product will be available OTC in stores starting in late January 2008, J&J says in a Nov. 16 release. The firm received approval for Zyrtec in 5 mg and 10 mg tablets, 5 mg and 10 mg chewable tablets and 1 mg/mL syrup. The once-daily drug is indicated for relieving indoor and outdoor allergy symptoms of sneezing, runny nose and watery eyes for up to 24 hours in adults and children; the drug also relieves itching due to hives, J&J says...

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