You are here

Generic Zyrtec Receives Tentative Approval

JERUSALEM--(BUSINESS WIRE)--Sept. 22, 2004--Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA - News) announced today that the U.S. Food and Drug Administration has granted tentative approval for the Company's ANDA for Cetirizine Hydrochloride Tablets, 5 mg and 10 mg. Final approval is anticipated upon expiration of patent protection on December 25, 2007.

Teva's Cetirizine HCl Tablets are the AB-rated generic equivalent of Pfizer's antihistamine product Zyrtec® Tablets, a product indicated for treatment of allergic rhinitis and chronic idiopathic urticaria.

The brand product has annual sales of approximately $1.2 billion.

Source: Teva Pharmaceutical Industries Ltd.

Recent Headlines

Disrupting Gut Microbiome Could Be Key
Drug Boosts Levels of Natural Endocannabinoids
Judicious Use of Antibiotics May Not Be Enough To Defeat Bacteria That Carry On By Going Into a Dormant State
KRAS Oncogene Is a Problematic Target So Researchers Are Trying Workdarounds
Understanding Neural Ensembles in Infralimbic Cortex May Lead To Improved Addiction Treatment
Vitamin E Found in Samples Around the Country
Study Links Them to Premature Death
Nag With Texting and a ‘Winners Circle’
How Serotonin and Fluoxetine Affect Microbiota Residing in the Gut