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Able Labs gets FDA nod for Bethanechol Chloride tabs
South Plainfield | Friday, July 30, 2004, 08:00 Hrs  [IST]

Able Laboratories Inc has received US FDA approval for its Abbreviated New Drug Applications for Bethanechol Chloride Tablets, USP 5mg, 10mg, 25mg and 50mg, which are therapeutically equivalent to Urecholine Tablets, 5mg, 10mg, 25mg and 50mg of Odyssey Pharmaceuticals, Inc.

The total sales for Able's newly approved drugs (used in the treatment of acute postoperative and postpartum non-obstructive urinary retention and for neurogenic atony of the urinary bladder with retention), is estimated to be approximately $55 million according to recent market data, the release from Able said.

Able, for 2004, has received 14 ANDA approvals to-date (nine within the last two months) compared with 13 approvals for full year 2003.

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