Mylan announced that USFDA has approved balsalazide disodium ANDA, which is a generic version of Salix Pharmaceuticals Ltd.'s key drug Colazal.
The drug treats ulcerative colitis, which is an inflammation of the rectal and colon lining that causes bleeding, frequent bowel movements and diarrhea. Colazal sales climbed to $31.1 million during the third quarter and accounted for nearly half of Salix's revenue.
Mylan's generic Colazal will enter the market against generic versions from Apotex and Roxanne, which also got FDA approval. Salix has partnered with Watson Pharmaceuticals Inc. to make a generic version of Colazal, in an attempt to offset the impact of wider competition.
The drug treats ulcerative colitis, which is an inflammation of the rectal and colon lining that causes bleeding, frequent bowel movements and diarrhea. Colazal sales climbed to $31.1 million during the third quarter and accounted for nearly half of Salix's revenue.
Mylan's generic Colazal will enter the market against generic versions from Apotex and Roxanne, which also got FDA approval. Salix has partnered with Watson Pharmaceuticals Inc. to make a generic version of Colazal, in an attempt to offset the impact of wider competition.
Watson pharma to market authorized generic of Colazal
Pursuant to a supply and distribution agreement with Salix Pharmaceuticals, Ltd, Watson Pharma, Inc, will market and sell an authorized generic of Colazal (balsalazide disodium) capsules 750 mg, the company's anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Watson will launch the authorized generic product immediately.Carolyn Logan, president and chief executive officer, stated, "Salix is committed to aggressively protecting its Colazal business and growing market share in the inflammatory bowel disease market. As part of our life cycle management program for Colazal, we are extremely pleased to partner with Watson to market and sell the authorized generic of Colazal. Watson is a major supplier of generic pharmaceutical products, and, with decades of experience and impressive expertise in the generics business, should be positioned to maximise our generic business."Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the company's 150-member gastroenterology specialty sales and marketing team.Colazal (balsalazide disodium) capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of Colazal beyond 12 weeks has not been established. Colazal was well tolerated in clinical studies. In clinical trials, patients reported the following adverse reactions most frequently: headache (8 per cent ); abdominal pain (6 per cent ); diarrhoea (5 per cent ); nausea (5 per cent ); vomiting (4 per cent ); respiratory infection (4 per cent ); and arthralgia (4 per cent ). Withdrawal from therapy due to adverse reactions
Pursuant to a supply and distribution agreement with Salix Pharmaceuticals, Ltd, Watson Pharma, Inc, will market and sell an authorized generic of Colazal (balsalazide disodium) capsules 750 mg, the company's anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Watson will launch the authorized generic product immediately.Carolyn Logan, president and chief executive officer, stated, "Salix is committed to aggressively protecting its Colazal business and growing market share in the inflammatory bowel disease market. As part of our life cycle management program for Colazal, we are extremely pleased to partner with Watson to market and sell the authorized generic of Colazal. Watson is a major supplier of generic pharmaceutical products, and, with decades of experience and impressive expertise in the generics business, should be positioned to maximise our generic business."Salix Pharmaceuticals, Ltd., headquartered in Raleigh, North Carolina, develops and markets prescription pharmaceutical products for the treatment of gastrointestinal diseases. Salix's strategy is to in-license late-stage or marketed proprietary therapeutic drugs, complete any required development and regulatory submission of these products, and market them through the company's 150-member gastroenterology specialty sales and marketing team.Colazal (balsalazide disodium) capsules 750 mg, is an anti-inflammatory drug approved for the treatment of mildly to moderately active ulcerative colitis. Safety and effectiveness of Colazal beyond 12 weeks has not been established. Colazal was well tolerated in clinical studies. In clinical trials, patients reported the following adverse reactions most frequently: headache (8 per cent ); abdominal pain (6 per cent ); diarrhoea (5 per cent ); nausea (5 per cent ); vomiting (4 per cent ); respiratory infection (4 per cent ); and arthralgia (4 per cent ). Withdrawal from therapy due to adverse reactions
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