Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

FDA approves more children’s Zyrtec equivalents

This article was originally published in The Tan Sheet

Executive Summary

Taro Pharmaceuticals Industries receives FDA approval for its children's cetirizine hydrochloride oral solution 1 mg/mL preparation, the Hawthorne, N.Y.-based firm announces April 22. The product is equivalent to McNeil Consumer Healthcare's Children's Zyrtec Oral Solution. Citing industry sources, Taro says the allergy treatment generated annual U.S. sales of $160 million when it was available only by prescription. Indian drug firm Ranbaxy and Canadian generics manufacturer Apotex also recently received approval for private-label children's cetirizine. Allegan, Mich.-based private labeler Perrigo received approval for its children's Zyrtec equivalent April 9 and also markets generic versions of both adult-indicated Zyrtec products, original Zyrtec (cetirizine 5 mg) and Zyrtec-D extended-release tablets (cetirizine 5 mg/pseudoephedrine 120 mg) (1"The Tan Sheet" April 14, 2008, In Brief)...

You may also be interested in...



Taro gets generic Zyrtec go-ahead

FDA approves the Hawthorne, N.Y.-based company's abbreviated new drug application for 5-mg and 10-mg cetirizine hydrochloride tablets. Taro Pharmaceuticals said July 27 it previously received approval for an equivalent of Johnson & Johnson/McNeil's Children's Zyrtec Oral Solution (1"The Tan Sheet" April 28, 2008, In Brief). FDA has already approved private-label versions of the OTC allergy drug manufactured by Perrigo, Sandoz, Ranbaxy and Mylan

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)...

Inovio Confirms Frontrunner Status In COVID-19 Vaccine Race, But Can It Prove Skeptics Wrong?

Its ‘virus chasing’ habits has given Inovio a bad reputation. But with backing from CEPI and Bill Gates, it has a chance to prove the doubters wrong.

Topics

UsernamePublicRestriction

Register

PS101588

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel