Glenmark Pharmaceuticals Inc (GPI), the US subsidiary of Glenmark Pharmaceuticals Limited (Glenmark), has initiated the marketing and distribution of nabumetone tablets and hydroxyzine hydrochloride tablets in the US market.
Glenmark has initiated marketing and distribution on final approval from the US Food and Drug Administration for an Abbreviated New Drug Application (ANDA) for nabumetone tablets in 500mg and 750mg strengths and hydroxyzine hydrochloride tablets in 10mg, 25mg and 50mg strengths, through its partnership with InvaGen Pharmaceuticals Inc (InvaGen). Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis
The company will exclusively market and distribute nabumetone and hydroxyzine hydrochloride tablets while InvaGen will be responsible for their manufacture and supply. All development, regulatory costs and profits on nabumetone and hydroxyzine hydrochloride tablets' sale in the US will be shared equally between Glenmark and Invagen. According to IMS Health data, for the 12 month period ending December 2007, the market size of nabumetone was USD 97 million.