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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— a move sparked by the FDA’s rejection of a consent decree proposal that would have allowed the firm to relaunch its withdrawn drug products without having to resubmit abbreviated new drug applications (ANDAs).
Perrigo has voluntarily recalled all lots of its concentrated infants’ oral drops due to possible confusion over the proper dosing of the OTC pain and cold treatments for children under the age of 2.
A panel of Canadian health experts has recommended the return to the market of Merck’s arthritis pain drug Vioxx — a potential move that could help the firm in its legal battles over the withdrawn drug, according to an analyst.
Purdue Pharma plans to reformulate its narcotic painkiller Palladone to reduce the alcohol interaction risk that prompted the FDA to request the drug be withdrawn from the U.S. market.
Embattled generic drugmaker Able Laboratories, which in May voluntarily recalled its entire product line because of quality problems, is hoping to restart its operations under a consent decree agreement it has proposed to the FDA.
An FDA advisory committee has recommended that three asthma drugs remain on the market despite concerns the products might cause severe asthma attacks in a small number of patients.
Purdue Pharma plans to reformulate its narcotic painkiller Palladone to reduce the alcohol interaction risk that prompted the FDA to request the drug be removed from the market.