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:
You must be a registered member of MMM to post a comment.

Email Newsletters

More in News

Five things for Pharma Marketers to know: Friday, August 29

Five things for Pharma Marketers to know: Friday, ...

Takeda closes out a good-news, bad-news kind of week, AstraZeneca adds a new clinical trial for its experimental PD-1, and researchers link a funeral to the Ebola outbreak.

Amgen sends PCSK9 to FDA

Amgen sends PCSK9 to FDA

Evolocumab holds the FDA's first filed biologics license application for the class.

Consultants expect M&A tempo to continue

Consultants expect M&A tempo to continue

PwC anticipates that divestitures will fuel late-2014 deals, but notes that the noise around early deals and the financials don't fully match up.