Four bethanechol ANDAs OKed for Able

Able Laboratories says that it has received Food and Drug Administrationapproval 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 made by Odyssey Pharmaceuticals. The total sales for Able's newly-approved drugs (used in the treatment of acute post-operative and post-partum non-obstructive urinary retention and for neurogenic atony of the urinary bladder with retention), are estimated to be approximately $55 million, according to recent market data.

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