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

Astellas, DOJ settle for $7.3M

Astellas, DOJ settle for $7.3M

Astellas has settled a False Claims case with the Department of Justice over the 2010-2013 marketing of an antifungal medication. Astellas denies the allegations.

Boehringer drug lands US, EU orphan tag

Boehringer drug lands US, EU orphan tag

The experimental Breakthrough Therapy treatment is for acute myeloid leukemia.

Omnio app moves to smartphones

Omnio app moves to smartphones

Physicians Interactive is introducing the third wave of its Omnio app, making the tablet-only tool available for iPhones and Android phones.