ABLE WILL SELL ASSETS IN WAKE OF PROPOSAL REJECTION
The saga of troubled generic drugmaker Able Laboratories took yet another turn yesterday when the company said it intends to sell its assets - a move sparked by the FDA's rejection of a consent decree proposal that would have allowed the firm to relaunch its withdrawn drug products without having to resubmit abbreviated new drug applications (ANDAs).
Cranbury, N.J.-based Able in May voluntarily recalled its entire product line because of quality problems. The firm submitted a consent decree proposal to the FDA in July that it hoped would pave the way for an eventual return to the market.
The company's proposal represented a departure from long-standing FDA policy, which, in situations involving data integrity problems, calls for the offending manufacturer to withdraw its ANDAs and resubmit the applications with new data for full FDA review. Able acknowledged that its proposal was unusual, but the company said it felt the FDA should make an exception in its case because of the company's "extraordinary" voluntary actions.
The FDA carefully considered the proposal, according to Able, but ultimately decided to reject the consent decree plan. "Although recognizing the company's actions, the FDA advised that the most expeditious relaunch of [Able's] products would nevertheless require withdrawal, resubmission (with new data) and agency review of ANDAs for products that Able desired to manufacture in the future," Able said recently. "In the view of Able's management, even under an expedited approach, FDA review of the ANDAs could take up to 18 months in each case."
Able, which last month filed a voluntary petition to reorganize under Chapter 11 of the U.S. Bankruptcy Code, said the FDA's decision will prevent it from returning any products to market because its reorganization plan calls for it to relaunch certain products in a more timely fashion.
Prior to its recall, Able marketed more than 40 FDA-approved products, including generic versions of Abbott Laboratories' Vicodin (acetaminophen/hydrocodone bitartrate), Novartis' Ritalin (methylphenidate HCl) and GlaxoSmithKline's Compazine (prochlorperazine).