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Industry continues to be divided on whether to include interchangeability statements on biosimilar labels, with Amgen taking the lead in support and Merck taking the lead against in comments on the FDA’s March draft biosimilar labeling guidance. Read More
Two FDA advisory committees recommend the approval of Egalet's opioid Arymo to manage severe pain that requires daily, long-term treatment when alternatives are unavailable, with three abuse-deterrent labels. Read More
An FDA advisory committee recommended FDA approve Amgen’s biosimilar of the AbbVie’s blockbuster drug Humira and Sandoz’s biosimilar of Amgen’s Enbrel. Read More
Mylan has agreed to shed two generics that treat muscle pain and epilepsy to allay FTC antitrust concerns, clearing the way for its $7.2 billion acquisition of Meda. Read More
The FDA approved eight ANDAs for AstraZeneca’s blockbuster cholesterol drug Crestor after a federal judge denied the company’s bid to stave off the approvals. Read More
The FDA has shot down three citizen petitions seeking agency action on biosimilar labeling, arguing that a draft guidance issued in April is sufficient to address most of their concerns. Read More
The FDA is advising generic drugmakers looking to revise their labels without the fallback of a reference product that they have only one route: supplemental submissions. Read More
An anticipated uptick in generic drug submissions is leading the FDA to lower its fees for approval applications and supplemental filings next fiscal year. Read More
The UK’s drug pricing watchdog is recommending reimbursement of Celgene’s plaque psoriasis drug Otezla, provided that the company lowers its price. Read More