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Canadian regulators plan to ratchet up scrutiny of patent litigation settlements between brand and generic drugmakers in search of antitrust deals that delay generic competition. Read More
A new bipartisan House bill would stop brandmakers from relying on a drug-control program to deny generics firms the batch samples they need to put together an ANDA. Read More
Seven generics firms are set to begin distributing licensed versions of Gilead’s blockbuster hepatitis C drug Sovaldi in 91 developing countries, as part of a deal to expand access to the expensive therapy. Read More
Connecticut’s attorney general has joined a growing chorus of voices urging the FDA to immediately approve a generic version of AstraZeneca’s acid-reflux drug Nexium, either by clearing first-filer Ranbaxy’s version or by finding that the Indian firm forfeited its exclusivity because of rampant delays. Read More
A federal judge earlier this month affirmed the FDA’s decision to approve generic versions of Hospira’s sedative Precedex under a pathway that allows manufacturers Mylan and Par to proceed with products that “carve out” the brand firm’s method-of-use patent in the drug’s labeling. Read More
The FDA warned an active pharmaceutical ingredient manufacturer for not paying its facility user fees. However, the company says it hasn’t made APIs since 2008. Read More
Generics makers with first-to-file ANDA status say they are frustrated by the FDA’s slow approval times, claiming their 180-day market exclusivity period is jeopardized by agency inaction. Read More
A federal judge has tossed out all claims brought against Pfizer and Ranbaxy by retailers and distributors in a larger lawsuit that alleges the two companies colluded to delay a generic version of Pfizer’s blockbuster cholesterol drug Lipitor.
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The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency said. Read More
The Federal Trade Commission is suing AbbVie and its partner Besins Healthcare, along with generic firm Teva, over an alleged pay-for-delay deal that put off generic entry of AbbVie and Besins’s blockbuster testosterone gel AndroGel 1%. Read More