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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
The FDA has approved the first treatment for sexual desire disorders, Sprout Pharmaceutical’s Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder in premenopausal women. 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
Amgen agreed Tuesday to pay $71 million to 48 states and the District of Columbia to resolve allegations it promoted biologics Aranesp and Enbrel based on misleading claims. Read More
The China State Council is calling for sweeping reforms of the country’s drug regulatory system, including accelerated approvals of novel drugs, specified timelines for deciding applications and increased public access to applications and information. Read More
U.S. Sen. Joe Manchin (D-W.Va.) says he will call for a Senate investigation into the FDA’s decision to allow OxyContin to be prescribed to children as young as 11. Read More
Seattle Genetics has received FDA approval for its cancer drug Adcetris to treat patients with Hodgkin lymphoma who are at high risk of relapse following an autologous haematopoietic stem cell transplant to help curb the disease’s progression. Read More
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
HHS has contracted with San Diego-based Pfenex Pharmaceuticals to develop an anthrax vaccine that is effective after exposure — under an agreement valued at up to $143 million. Read More
The FDA has granted orphan drug designation to La Jolla Pharmaceutical for two novel compounds to treat fibrodysplasia ossificans progressiva, a genetic mutation that turns muscle into bone. Read More