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The FDA expects manufacturers of genetically engineered products that could be harmful if released into the wild to submit environmental assessments (EAs) along with their biologics applications. Read More
Avanir Pharmaceuticals has settled with generic firm Ranbaxy over its bid to produce a version of the brand manufacturer’s Nuedexta, the first drug approved in the U.S. to treat pseudobulbar affect (PBA). Read More
GlaxoSmithKline’s vaccine plant in Canada received an FDA warning for a bevy of quality violations such as failing to prevent contamination in its manufacturing processes and water system. Read More
The FDA said Friday it would require a warning label on all testosterone products detailing the general risks of developing blood clots in the veins. Read More
The FDA late Friday approved Cubist Pharmaceuticals’ antibiotic Sivextro, the second drug approved for acute bacterial skin and skin structure infections as part of the agency’s effort to encourage the development of new antibiotics as a bulwark against growing drug resistance. Read More
Akorn Enterprises, or its new subsidiary Hi-Tech Pharmacal, was required to sell the marketing rights for five generic drugs to Watson Laboratories to settle federal charges that Akorn’s acquisition of Hi-Tech was anticompetitive, the FTC said. Read More
Pfizer-subsidiary Wyeth is claiming immunity in a long-running antitrust lawsuit involving an alleged pay-for-delay generics scheme with Teva, but a group of pharmaceutical purchasers aren’t buying the argument. Read More
The FDA has slapped two generic manufacturers with separate warning letters for not paying registration fees on their facilities under GDUFA. Read More