FDA Approves Ranbaxy's Generic Claritin
Ohm Laboratories, a wholly owned subsidiary of Ranbaxy Laboratories, announced it has received FDA approval to manufacture and commercialize its generic loratadine orally disintegrating tablets, 10 mg.
The FDA's Division of Bioequivalence has determined the product to be bioequivalent to the reference-listed drug, Schering-Plough's Claritin Reditabs, a long-acting antihistamine agent that has annual sales of $58.7 million, Ranbaxy said.
Loratadine is indicated for the temporary relief of runny nose, sneezing, itching of the nose or throat, itchy watery eyes due to hay fever or other respiratory allergies in adults and children 6 and older, according to Ranbaxy.
"With Loratadine, Ohm will be launching another OTC product offering that represents a molecule with value and utility, marketed in the private label or store brand segment of the U.S. healthcare system," Robert Haywood, senior director of OTC sales and marketing at Ohm, said.
Ranbaxy also announced recently that has received Health Canada approval to manufacture and market RAN-Cefprozil tablets, 250 and 500 mg, and RAN-Cefprozil powder for oral suspension, 250 mg/5 mL.
Cefprozil is indicated for the treatment of upper respiratory tract infections, uncomplicated skin infections and urinary tract infections, according to Ranbaxy.