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The attorneys general of California and Alaska have issued subpoenas to AstraZeneca seeking information about its marketing practices for Seroquel (quetiapine fumarate), and the SEC has made an “informal inquiry” to the company regarding payments to foreign doctors and government officials, the company said.
Merck may have another blockbuster as the FDA approved its drug Januvia, which is the first treatment in a class of new diabetes drugs that improve the body’s ability to decrease high blood-sugar levels.
Data from preclinical animal experiments that preceded the calamitous clinical trial of the experimental gene therapy TGN1412 suggest that the drug should have been classified as higher risk than it actually was, and the trial participants should have received a lower dose, according to two researchers writing in the UK medical journal The Lancet.
The FDA has approved the first treatment in a class of new diabetes drugs that improve the body’s ability to decrease high blood-sugar levels, giving drug manufacturer Merck another potential blockbuster to add to its portfolio.
Shire Pharmaceuticals announced Andrx has filed an application to market a generic version of Shire’s attention-deficit/hyperactivity disorder (ADHD) drug Adderall XR.
Faced with a huge backlog of generic drug applications, the FDA’s Office of Generic Drugs (OGD) announced it is now using an electronic filing system — in use by another division of the FDA since 2000 — that the OGD said will make it more efficient at reviewing applications.
The FDA is proposing a new test to estimate the similarity between brand drugs and their generic equivalents, taking into account the variability in source brand drugs when deciding whether to grant generic drug applications, agency sources said.
Over the past 18 months the FDA has approved most new active drug ingredients after only one review, according to a report by Barnett International on U.S. drug approval trends.
The FDA in the past 18 months has approved most new active drug ingredients after only one review, but those under standard review require a second go-around far more often than those under priority review, according to a report by Barnett International on U.S. drug approval trends.