BIZ BriefsNine generic drug makers including three in New Jersey were approved by the U.S. Food and Drug Administration last week to sell knockoffs of Zyrtec, PfizerÂs prescription allergy fighter, as over-the-counter medicines, according to the FDA.
Manufacturers including Par Pharmaceutical Companies, Inc. of Woodcliff Lake, IndiaÂs Ranbaxy Laboratories Ltd. and IcelandÂs Actavis Group were among those approved to package cetirizine hydrochlorideÂthe active ingredient in Zyrtec that treats allergy symptoms such as runny nose, and itchiness from hivesÂin OTC products. Ranbaxy and Actavis have their U.S. headquarters in Princeton and Morristown, respectively.
Those products will join the branded version of OTC Zyrtec to be sold by Johnson & Johnson. As part of J&JÂs $16.6 billion purchase of PfizerÂs consumer health care division in 2006, J&J acquired the rights to switch Zyrtec to an OTC medicine and sell it in the United States when the drugÂs patent expired.
In November 2007, McNeil-PPC, Inc., a subsidiary of New BrunswickÂs J&J, won approval from the FDA to sell prescription Zyrtec and Zyrtec-D, which includes a decongestant, as OTC tablets and syrup, according to the drug maker. J&J said in a previous statement that it planned to start selling Zyrtec and Zyrtec-D as OTC medicines this month.
Prescription Zyrtec had sales of $1.3 billion for the 12 months ending September 2007, according to a Ranbaxy statement that quotes data from market research firm IMS Health Inc. of Norwalk, Conn.