FDA nod for Cetirizine Hydrochloride tablets

UNI
New Delhi, Aug 28:
Drug maker J B Chemicals and Pharmaceuticals Ltd today said it has received US Food and Drug Administration approval for its Abbreviated New Drug Application for Cetirizine Hydrochloride tablets.
The company would manufacture the anti-allergic formulations at its Panoli facility in Gujarat and is in the process of negotiations with its marketing partners in the US for the launch of the products there, it said in a statement.
Cetirizine tablets are now sold over-the-counter in the US .
It had sales of about 1-4 billion dollar prior to becoming an OTC product.
The company's formulations have been found to be bioequivalent to the innovator McNeil Consumer Healthcare's product 'Zyrtech'.