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The FDA slammed Cipher Pharmaceuticals for an email that contains overblown superiority claims promoting a cholesterol drug, the latest signal this year that the agency is scrutinizing drugmakers’ electronic promotions. Read More
The new rule establishing FDA powers to destroy suspected counterfeit and adulterated drugs could cause shortages if the agency doesn’t protect against officials destroying needed excipients that get caught up in an import dispute, according to PhRMA. Read More
Drugmakers say they will be forced to abandon social media due to proposed FDA requirements to present both risk and benefit information in character-limited social media messages — a requirement they contend the agency doesn’t even follow. Read More
The FDA warned Pacira Pharmaceuticals for touting unapproved uses of its analgesic Exparel, but the company says its labeling can back up the claims. Read More
Shire agreed to pay the federal government $56.5 million to settle allegations it peddled outlandish superiority claims for its attention deficit disorder drugs, including a sales pitch that Adderall XR could prevent poor school grades and traffic accidents. Read More
An HHS watchdog has urged the Centers for Medicare and Medicaid to work with manufacturers to ensure copayment coupons aren’t used on drugs covered under federal programs; a violation of anti-kickback laws. 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
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 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
The head of a non-profit that pushes for more products to be made in the U.S. is suing Apotex and Costco for selling a generic of the cholesterol drug Lipitor that didn’t indicate it was made in India. Read More
Generic drugs continued their market growth last year, rising two percentage points to 86 percent of all prescriptions dispensed in the U.S. market, according to a new study. Read More
New York’s attorney general has filed what may be a first-of-its-kind antitrust lawsuit against Actavis and subsidiary Forest Laboratories for seeking to switch patients on its Alzheimer’s drug Namenda to a newer formulation with longer lasting patents in order to stave off generic competition. Read More