TRENTON, N.J. -- Allergy sufferers who take the popular prescription medication Zyrtec are getting several options that don't require a prescription.
On Monday, the U.S. Food and Drug Administration gave approval for Ohm Laboratories to sell generic versions of Pfizer's pfe Zyrtec. The antihistamine, which doesn't make takers sleepy, generated about $1.3 billion in annual sales but lost patent protection in late December.
Ohm will sell the drug without a prescription under its chemical name, cetirizine hydrochloride, in five and 10 milligram doses. The medicine treats hives and allergy symptoms such as runny nose, sneezing and itching of the nose, throat and eyes.
Ohm, which sells generic, private label and non-prescription medicines in this country, is a subsidiary of Ranbaxy Laboratories, India's biggest drug company.
Jim Meehan, Ohm's vice president of sales and distribution, said the products will be launched immediately.
Last Friday, FDA approved two other companies to sell cetirizine hydrochloride as a generic, over-the-counter drug, also in five and 10 milligram doses. They are Caraco Pharmaceutical Laboratories of Detroit and Perrigo of Allegan, Mich. Perigo will sell the products under store-brand labels.
McNeil Consumer Healthcare, a unit of Johnson & Johnson jnj, said in November it had won approval to start selling brand-name Zyrtec over the counter this January. It acquired the "switch rights" to sell a non-prescription version of Zyrtec as part of its $16.6 billion purchase of Pfizer's consumer health care business at the end of 2006.