FDA to generics firms: OK to sell Zyrtec OTC

Share this article:
The FDA gave the nod to several generics firms to market copycat versions of the over-the-counter allergy drug Zyrtec (cetirizine).

Among the nine companies listed on FDA's Web site as having receiving approval are Mylan, which is the world's third-largest generics maker, Perrigo and Caraco Pharmaceutical Laboratories. The FDA had tentatively approved the applications in 2004, pending expiration of the drug's patents.

Johnson & Johnson won FDA approval to sell nonprescription Zyrtec in November after buying rights to the product in its $16.6-billion purchase of Pfizer's consumer unit in December 2006. J&J said it plans to launch the OTC version in January 2008 through its McNeil Consumer Healthcare unit.

McNeil will also distribute Zyretc-D 12 Hour (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg), which combines Zyrtec with a decongestant.

Zyrtec sales for the 12 months ending October 2007 were approximately $1.4 billion, according to Wolters Kluwer data cited by Perrigo.
Share this article:

Email Newsletters

More in News

Meaningful use not linked to quality: study

Meaningful use not linked to quality: study

A recent study of physicians found no correlation between following EHR meaningful use requirements and providing consistently higher quality of care.

Lilly Q1 sales dip

Lilly Q1 sales dip

US sales fell 34% during the quarter, largely due to lower demand and lower prices for off-patent Cymbalta and Evista.

Gilead reaps huge HCV sales, payer fury

Gilead reaps huge HCV sales, payer fury

Sovaldi's debut has been marked by plenty of criticism from payers and lawmakers, but the hep. C drug's launch, now confirmed to be the fastest of all time, has also ...