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

AstraZenca beefs up respiratory portfolio

AstraZenca beefs up respiratory portfolio

AstraZeneca has made an $875-million move to beef up its respiratory pipeline by making Almirall's lineup its own.

Amgen Q2 sales rise, company to lay off up to 2,900

Amgen Q2 sales rise, company to lay off ...

The majority of the layoffs will be in the US.

Doctors want to know how CMS plans to display Sunshine payment data

Doctors want to know how CMS plans to ...

Physician and industry trade groups are asking CMS to explain how context will be provided to the general public around the dollar sums drugmakers ascribe to doctors for things like ...