生物谷报道：继美国FDA控告Able Laboratories伪造实验数据，从而企图使其产品获得FDA通过，这一行为严重损害其公司的形象和产品的信誉，Able Labs 不得不撤回其产品。虽然Able Labs试图重新销售药物的计划时，又被FDA驳回。经过这一轮打击后，Able Labs 公司便申请进入破产程序，决定出售其资产，而不是重新生产。Able Labs称是在FDA驳回其重新销售药物的计划后，采取出售其资产的行动。
Able Laboratories Inc., which halted production and recalled its line of generic drugs in May, on Tuesday said it would sell the company instead of attempting to get financing and resume manufacturing.
It stock, which began the day above $1, tumbled to about a quarter, and the company acknowledged the stock is probably worthless.
Able said it decided to sell because federal regulators, who have said the company falsified test results, rejected the company's plan to return products to market quickly.
The company said its ability to get financing _ and continue in business _ depended on a timely turnaround, which no longer appears feasible.
Able, which filed for Chapter 11 bankruptcy reorganization last month, said it is unlikely that shareholders would get anything for their stock because proceeds of the sale would be "insufficient to pay all of the liabilities owed to secured and unsecured creditors."
The company had listed $59.5 million in assets and $9.5 million in debts in its July 18 filing in U.S. Bankruptcy Court in Trenton.
However, "The returns from the recall are going to exceed the assets," said Richard M. Shepperd, Able's director of restructuring. "When the customer returns goods, you have to give him a credit."
Shepperd said he could not yet give an estimate of how much a sale might yield.
The company does not need to convert its bankruptcy to a Chapter 7 liquidation to sell all its assets, he said.
The Cranbury-based company, which had made 46 generic versions of name-brand drugs for pain, inflammation, obesity and cardiovascular conditions, said it has not made any money since May 23 when it voluntarily halted manufacturing and recalled all its products.
It took that step following a series of recalls and an internal probe that uncovered problems with testing procedures for some of its drugs. CEO Dhananjay G. Wadekar soon resigned and the company's stock began to fall. His interim successor, Robert Mauro, resigned July 7.
The Food and Drug Administration has said Able created data so its drugs would appear to meet federal standards when they did not. In 41 incidents dating to 2001, drugs were found to have too much or too little of their active ingredients, but each time their strength was reported to be within legal limits, the FDA said.
On nine other occasions, Able failed to issue alerts about impure drugs, the FDA said.
On Tuesday, Able said it had proposed that the FDA allow it to re-launch its drugs under new management and with data verified by an independent consultant, without a full FDA review.
Able said that although such a course would be a departure from typical FDA procedures, the company believed it was justified because of its "extraordinary voluntary actions."
However, it said the FDA rejected the offer, and that the process to get each drug back to market would take up to 18 months. That would be too long to attract investors, Able said, leaving it little choice but to quit.
Able shares fell 86 cents, to 27 cents, in trading Tuesday on the Nasdaq.
