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AstraZeneca has sued India-based generics firm Zydus Cadila to block its bid for a version of the brand manufacturer’s acid-reflux drug Nexium. Read More
The European Medicines Agency wants to bring its policy on accessing drug safety reports in line with pharmacovigilance legislation, which aims to simplify reporting and increase data sharing among international organizations. Read More
Generics manufacturer Akorn must sell its rights to a pending ANDA for the tuberculosis drug rifampin before it can complete its $324 million acquisition of VersaPharm, the Federal Trade Commission said. Read More
The FDA has slapped a warning on an Italian active pharmaceutical ingredient manufacturer for deleting quality data, the latest indication the agency is serious about clamping down on poor manufacturing data integrity. Read More
Actavis initiated a consumer-level recall of its amoxicillin powder for oral suspension in New Zealand after pharmacists found glass particles in two bottles of the liquid antibiotic. Read More
Indian generics maker Sun Pharmaceutical is voluntarily recalling 41,127 bottles of the antidepressant venlafaxine HCl extended-release tablets over improper dissolution. Read More
Baxter is voluntarily recalling four lots of intravenous solutions in response to customer complaints of plastic and fiber particles in the product, its fourth recall this year related to particulates. Read More
After initially rejecting FDA’s authority, a Texas compounding pharmacy acceded to the agency’s request to cease production and recall all of its sterile products due to quality concerns. Read More
Hospira conducted its fourth recall in roughly two months due to contaminated products, leading to another quality headache for the injectables giant. Read More
The FDA asked healthcare professionals to watch out for drugs compounded by a Dallas-based pharmacy after a recent inspection revealed 22 lots of sterile drugs failed quality tests. Read More
The FDA has stepped up its enforcement of compounding pharmacy quality violations that occurred before a new law took effect that boosted agency powers, a move that some industry players contend is unjust. Read More
OTC drugmaker P&L Development received a Form 483 after investigators found the company didn’t test certain products for yeast and mold before release and for poor data integrity. Read More