Aug. 31, 2012 | Vol. 4 No. 35
Ranbaxy has withdrawn its approved ANDAs for 27 U.S. drugs to focus on other applications and fixing good manufacturing practice deviations that prompted a consent decree earlier this year.
The FDA has placed a “precautionary” clinical hold on Idenix Pharmaceuticals’ next-generation nucleotide polymerase inhibitor, IDX19368, being developed to treat hepatitis C (HCV) infection.
DePuy Synthes has issued a Class I recall of Synthes Hemostatic Bone Putty due to a risk the putty may ignite if it comes into contact with electrosurgical cautery systems under certain conditions during orthopedic surgery.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use has urged Pacira Pharmaceuticals’ cancer drug DepoCyte be recalled in certain EU countries, citing “manufacturing deficiencies” found at the company’s San Diego, Calif., facility.
Sun Pharmaceuticals’ Caraco unit may resume some of its Detroit and Wixom, Mich., operations after recent FDA inspections show it is in compliance with a 2009 consent decree.
European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and improves potential confusion and delays for selecting the appropriate language when using a device.
Dr. Reddy’s can once again export products from its Morelos, Mexico, manufacturing facility to the U.S. thanks to an FDA closeout letter and the removal of an import alert that stemmed from an unfavorable agency inspection more than a year ago.
Genzyme is voluntarily recalling nine lots of its kidney transplant drug Thymoglobulin after one product lot failed a periodic stability test, the Sanofi subsidiary says.
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