Andhracafe.com- The United States Food and Drugs Administration (USFDA)’s arthritis advisory committee has rejected Merck’s Arcoxia’ (etoricoxib) in the US for its side-effects such as heart attack.
The move is likely to affect major Pharma firms in the country a ban on the sale of the generic version of Merck's pain management drug in the Indian market.Etoricoxib belongs to the Cox II inhibitor class of drugs (a new generation pain management drug).
Of the Cox II drugs, which include etoricoxib, celecoxib, valdecoxib and parecoxib, two drugs - rofecoxib (Merck’s Vioxx) and valdecoxib (Pfizer’s Bextra) - are already banned by leading drug regulators, including in India.
The National Pharmacovigilance Advisory Committee (NPAC) has also included Cox II inhibitors among the 10 categories of drugs that are specially monitored for possible adverse drug reaction. Any adverse ruling by the US FDA is likely to trigger a corresponding move by the NPAC - leading to a ban on the drug.
The major companies that manufacture etoricoxib formulations are Ranbaxy (Etrobax), Dr Reddys, Cipla (etozox), Zydus Cadila (Nocoxia), Torrent (Torcoxia), Emcure, Hetero, Elder Pharma, Alkem (Evaxx), Emcure, Nicholas Piramal (Etody), Sun Pharma, Wockhardt, Unichem, Glenmark (Kretos), Micro Labs and Alembic.