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News Breaks
March 6, 2014
10:14 EDTJNJFDA approves label change for Doribax describing increased risk of death
The FDA announced it has concluded that Doribax, an antibacterial drug that has been used to treat patients who develop pneumonia while on ventilators, carries an increased risk of death and lower clinical cure rates compared to use of imipenem and cilastatin for injection, marketed in the U.S. under the name Primaxin. "Based on our analysis of data from a three-year clinical trial that was prematurely stopped in 2011 due to these safety concerns, we have approved changes to the Doribax drug label that describe these risks," the FDA stated. The FDA said Doribax is still considered safe and effective for its FDA-approved indications - treatment of adults with complicated intra-abdominal infections and complicated urinary tract infections. Doribax is marketed outside Japan by Johnson & Johnson.
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June 17, 2015
07:21 EDTJNJGeneric ADHD drugs still sold despite FDA non-equivalance finding, NYT reports
The FDA announced last November that two generic versions of Johnson & Johnson's (JNJ) Concerta ADHD drug, one made by Mallinckrodt (MNK) and the other by UCB, could no longer be considered the equivalent of the branded drug after tests and analyses suggested that their effectiveness began to wear off much more quickly, but the drugs are still being sold despite an FDA mandated deadline having passed for the companies to either prove the drugs were equivalent or remove them from the market, said The New York Times. The report noted a third generic product, sold by Actavis (AGN), was found to be equivalent to the branded Concerta. Reference Link

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