Caraco receives tentative FDA approval for generic Zyrtec
DETROIT Caraco Pharmaceuticals has received tentative approval from the Food and Drug Administration for a generic version of Pfizer’s antihistamine drug Zyrtec, in a chewable form.
The application is for the 5 and 10 mg versions of the drug, which is indicated for the relief of seasonal nasal allergy symptoms in adults and children 2 years of age and older.
Final marketing approval should come following the expiration of Pfizer’s patent on the drug on Dec. 25. Zyrtec had sales of almost $1.6 billion in 2006.