Glenmark US arm gets USFDA nod for anti-allergy tablets

NEW DELHI: Pharma major Glenmark today said its US arm has received final approval from the US health regulator to market generic Levocetirizine Dihydrochloride tablets used for treating allergies in the American market.

" Glenmark Generics Inc have been granted final approval for their Abbreviated New Drug Application (ANDA) from the United States Food and Drug Administration for Levocetirizine Dihydrochloride 5 mg tablets," Glenmark said in a filing to the Bombay Stock Exchange (BSE).

The tablets are generic version of UCB Inc's Xyzal tablets, it added.

Quoting IMS Health, Glenmark said: "Total US sales as reported by IMS Health for the 12-month period ending December 2010 were approximately USD 231 million."

Levocetirizine Dihydrochloride tablets are used for relief of symptoms associated with allergic rhinitis, which is an allergic inflammation of the nasal airways.

Shares of Glenmark were today trading at Rs 277.50 in the afternoon trade at BSE, down 1.63 per cent from its previous close.