The FDA gave the nod to several generics firms to marketcopycat versions of the over-the-counter allergy drug Zyrtec (cetirizine).
Among the nine companies listed on FDA’s Web site as having receivingapproval are Mylan, which is the world’s third-largest generics maker, Perrigo andCaraco Pharmaceutical Laboratories. The FDA had tentatively approved the applicationsin 2004, pending expiration of the drug’s patents.
Johnson & Johnson won FDA approval to sell nonprescriptionZyrtec in November after buying rights to the product in its $16.6-billionpurchase of Pfizer’s consumer unit in December 2006. J&J said it plans to launchthe OTC version in January 2008 through its McNeil Consumer Healthcare unit.
McNeil will also distribute Zyretc-D 12 Hour (cetirizine HCl5 mg/pseudoephedrine HCl 120 mg), which combines Zyrtec with a decongestant.
Zyrtec salesfor the 12 monthsending October 2007 were approximately $1.4 billion, according to Wolters Kluwer data cited by Perrigo.