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The FDA has withdrawn three holdout ANDAs for products containing the narcotic propoxyphene due to safety issues, but the drugs have likely long since been discontinued, the agency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
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
Boston-based Epirus Biopharmaceuticals has received final approval in India for its biosimilar of the autoimmune therapy Remicade, making it the first biosimilar of the product in that country. Read More
The FDA for the first time has published a reference list for biologics, known as the Purple Book, that will list all brand products and any biosimilars with which they are interchangeable. 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
The FDA’s database of inactive drug ingredients needs a complete overhaul to better facilitate ANDA filings, say generics makers who laid out a variety of other shortfalls they see in the agency’s generic drug approval process. Read More
Generic drugmakers submitting ANDAs indicating impurities in proposed products that exceed established thresholds must provide detailed justification to avoid having the application rejected, the FDA said. Read More
The FDA needs to clarify whether its 10-day ANDA correspondence clock starts ticking once a manufacturer receives the agency’s communication or at the moment the agency mails it, say generics firms, which also urge the FDA to start sending all communications by fax or email. Read More
European regulators have approved Eli Lilly and Boehringer Ingelheim’s insulin glargine drug Abasria, a biosimilar version of Sanofi’s blockbuster product Lantus. Read More