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The Federal Trade Commission has reached a settlement with Par Pharmaceuticals and Concordia Pharmaceuticals that, if finalized, would prohibit them from restraining trade in the sale of generic Kapvay, an attention deficit hyperactivity disorder drug. Read More
The European Medicines Agency expects to receive the first generic drug application under a program that lets companies file joint submissions in the EU, Australia, Canada, Taiwan and Switzerland during the fourth quarter of this year. Read More
Australian regulators have approved Hospira’s Inflectra as the country’s first monoclonal antibody biosimilar, a version of Janssen’s autoimmune disease therapy Remicade. Read More
Amgen made a last-ditch effort to block competition for its chemotherapy product Neupogen, asking the Federal Circuit to stop Sandoz’s Sept. 2 launch of its Zarxio biosimilar. Read More
Just days before Sandoz is expected to launch Zarxio, its biosimilar of Amgen’s chemotherapy drug Neupogen, the FDA issued a proposed rule changing both drugs’ official names, at least temporarily. Read More
The FDA is seeking input on how it can make its Inactive Ingredients Database more useful and user-friendly, following complaints by generic drug and excipient makers that the current format delays ANDA filings. Read More
Industry questioned whether the FDA has the legal authority to enforce its quality metrics guidance during an Aug. 24 public meeting on the draft document. Read More
Mylan continues to breathe down Perrigo’s neck, announcing that two-thirds of votes cast during Friday’s shareholders meeting support the hostile takeover of the Dublin-based company. Read More
The FDA is amending its color additive regulations to allow for the use of spirulina extract in coating formulations for drug tablets and capsules — giving drugmakers an alternative blue color that is exempt from safety certification requirements. Read More
The FDA is questioning Mylan’s ability to achieve overall GMP compliance at three injectables manufacturing plants in India after finding serious deviations that should have been corrected after the drugmaker acquired Agila in December 2013. Read More
CDER has revised its policies and procedures guide on responding to inquiries about ANDAs, clarifying responsibilities for Office of Generic Drugs and Office of Pharmaceutical Quality staff. Read More
A drug pricing watchdog was rebuffed on Aug. 25 in its attempt to get the U.S. Patent and Trademark Office to review two patents on Acorda Therapeutics’ blockbuster multiple sclerosis drug Ampyra — the first of 18 petitions the Coalition for Affordable Drugs has filed with the agency since February. Read More