April 11, 2012 | Vol. 29 No. 8 | Full Issue in PDF Format
In the latest patent commotion over Provigil, Mylan Pharmaceuticals is suing the FDA over its recent decision to grant Teva sole first-filer status for a generic of the sleep disorder drug, saying the FDA overlooked an anti-competitive legal loophole.
As the FDA’s backlog of ANDAs continues to grow, it’s become increasingly common for generic-drug makers to lose their 180-day exclusivity by not gaining timely tentative approval.
The FDA and HHS may need to think twice before taking enforcement actions that could lead to drug shortages.
Companies seeking to market biosimilars may have more success getting their products approved in the U.S. than in other highly regulated markets, thanks to the FDA’s “step-wise” guidance.
A bevy of generic manufacturers have launched generic versions of AstraZeneca’s blockbuster antipsychotic Seroquel soon after a federal judge dismissed the drugmaker’s attempts to block competition.
The FDA has debarred four former quality control officials with New Jersey-based Able Laboratories, the generic-drug maker behind an infamous 2005 recall of its entire product line.
Generic giant Ranbaxy has launched additional generic Lipitor tablets, shipping them from its Mohali facility in Punjab, India, which it hopes will supply different generic products to several markets.
Sen. Richard Blumenthal (D-Conn.) called the FDA’s response to drug shortages “inadequate,” saying lawmakers need to give the agency more tools and mandates to correct the issue.
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