FDAnews Drug Daily Bulletin
Nov. 2, 2012 | Vol. 9 No. 216
Ameridose is recalling all of its unexpired product as an ongoing FDA inspection of its Westborough, Mass., facility has raised sterility concerns.
Ranbaxy has begun marketing an authorized generic of Daiichi Sankyo’s dry-mouth treatment Evoxac in the U.S. per an agreement with the Japanese drugmaker.
Japan’s Pharmaceutical and Medical Devices Agency (PMDA) cited increasing regulatory cooperation with China and South Korea in saying it will now accept new drug applications that rely on well-designed, well-conducted global clinical trials in the neighboring East Asian nations.
SigmaPharm sought a fresh start in its long-running antitrust fight with King Pharmaceuticals and Mutual Pharmaceutical, which it accuses of masterminding a conspiracy to suppress the release of generic forms of the muscle relaxer Skelaxin and to rob it of millions in royalties.
Johnson & Johnson is making more headway in restoring supplies of a crucial cancer drug unavailable to many patients since the contract manufacturer producing it, Ben Venue Laboratories, shut down a year ago due to serious contamination and other quality problems at its Ohio factory.
Canadian and Swiss health authorities lifted a ban on Novartis’s flu vaccines on Wednesday after the drugmaker showed they posed no risk to safety.
Watson Pharmaceuticals announced that it will adopt a new name — Actavis, which will come into force from 2013.
BioMarin Pharmaceutical has licensed North American rights to its EC-approved orphan drug Firdapse (amifampridine phosphate) to Catalyst Pharmaceutical Partners, and is making a $5 million investment in Catalyst to support the latter’s development of the drug in the U.S.
Sihuan Pharmaceutical Holdings has received a new drug certificate and production approval for Roxatidine Acetate Hydrochloride for injection.
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