Lupin receives US FDA approval for generic formulation; up two per cent

Bhagyashree Vivarekar / 30 Dec 2016

Lupin receives US FDA approval for generic formulation; up two per cent

Lupin Ltd today announced that it has received tentative approval for its Balasalazide Disodium tablet 1.1 gm from the United States Food and Drug Administration (USFDA) to market a generic version of Salix Pharmaceuticals Inc’s Giazo Tablet 1.1 gm.

Lupin receives US FDA approval for generic formulation; up two per cent

Lupin Ltd today announced that it has received tentative approval for its Balasalazide Disodium tablet 1.1 gm from the United States Food and Drug Administration (USFDA) to market a generic version of Salix Pharmaceuticals Inc’s Giazo Tablet 1.1 gm. The filing is from Lupin’s Goa manufacturing facility.

Lupin’s Balasalazide Disodium tablet 1.1 gm is AB rated generic equivalent of Salix Pharmaceuticals Inc’s Giazo tablet 1.1 gm. Balasalazide Disodium tablet is indicated for the treatment of mildly to moderately active ulcerative colitis in male patients 18 years of age and older.

Giazo tablet had US sales of USD 0.79 million (IMS MAT September 2016).
Lupin is a transnational pharmaceutical company developing and delivering a wide range of branded and generic formulations, biotechnology products and APIs globally. The company is a significant player in the cardiovascular, diabetology, asthma, pediatric, CNS, GI, anti-infective and NSAID space and holds a global leadership position in anti-TB segment.

After the company’s announcement, its stock price hit the day high of Rs 1490 on the BSE. As compared to previous close of Rs 1466.30, Lupin today opened at Rs 1469.95 and rose almost 2 per cent in today’s trade.

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