Glenmark commenced shipping immediately upon final approval from the FDA 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. This recent approval expands Glenmark’s portfolio to 28 generic products for the US market. The company has over 35 ANDAs undergoing review with the FDA for approval or launch.
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’s sale in the US will be shared equally between Glenmark and Invagen.
Nabumetone is a non-steroidal anti-inflammatory drug and is used to treat pain or inflammation caused by arthritis. Hydroxyzine belongs to a group of medicines called sedating antihistamines and is used in the treatment of anxiety.