May 22, 2013 | Vol. 30 No. 11 | Full Issue in PDF Format
Generic drugmaker Ranbaxy said May 13 it has agreed to a $500 million settlement with the Department of Justice following allegations of poor data integrity and manufacturing practices at three of its Indian facilities and a facility in Upstate New York.
Following weeks of speculation, Actavis said May 20 it will acquire Warner Chilcott in an all-stock transaction valued at $8.5 billion.
Industry stakeholders will have an opportunity to shape the FDA’s fiscal 2014 regulatory science roadmap for generic drugs during a June 21 public meeting at the agency’s headquarters.
Blocking imports of every shipment of active pharmaceutical ingredient (API) intended for compounding is an impossible feat requiring resources beyond the FDA’s means, the agency told an appeals court May 13, calling KV Pharmaceuticals’ claims it should have done so “absurd.”
All eyes will be on California this week as it joins a growing list of states trying to decide how to regulate the substitution of biosimilar drugs for their more costly brand counterparts.
Reps. Tim Ryan (D-Ohio) and Nita Lowey (D-N.Y.) have introduced legislation aimed at ensuring patients with Celiac Disease or other gluten sensitivities can safely take FDA-approved drugs.
Jazz Pharmaceuticals told investors May 6 it expects the FDA to require modifications to the current risk evaluation and mitigation strategy (REMS) for its highly controlled narcolepsy drug Xyrem, a move some analysts say could expand market opportunities for generic competitors.
The White House May 13 sought to block a lower court judge’s order requiring the FDA to remove all age restrictions from the emergency contraceptive known as Plan B One-Step.
GOP House leaders are investigating the brief tenure of Leona Brenner-Gati in the wake of the former FDA acting deputy commissioner’s sudden departure earlier this month.
The FDA May 10 denied Endo Pharmaceuticals’ citizen petition requesting the agency acknowledge that its noncrush-resistant version of its opioid painkiller Opana ER was withdrawn from the market for safety reasons, a move that would have blocked generic versions of the drug.
A federal judge handed Shire a victory May 8, ruling that Actavis’ generic version of Lialda, indicated for ulcerative colitis (UC), infringed the company’s ‘720 patent.
French drugmaker Sanofi-Aventis was fined $52.6 million by the French competition authority May 13 for marketing practices that discouraged sales of generic versions of the company’s blood thinner Plavix.
Congressional carping that the FDA is taking too long to decide if hydrocodone combination products should be further restricted is well-intentioned but dismisses the fine line between enforcement and ensuring pain medications are available to those who need them, experts say.
Former U.S. trade officials and pharma industry experts May 14 called on Congress to investigate India’s trade policies that impede innovation.
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