Weekly Roundup – 12-13-13

Ho Ho Ho.  Sort of.  Gifts not yet bought, much less wrapped.  In fact, ideas for buying gifts seem not to be forthcoming.  Cards sitting in their boxes without addresses or messages written inside.  Crowded stores.  No parking.  Traffic.  It is the sort of thing that can make one feel stressed.  And then one becomes aware of the setting sun at only 5 PM and realizes that this is the season that is all about the return of light which will start ebbing our way again in just one week. And the stress dissipates.

As we wind up the year, here is how we wind up the week:

  • FDA Approves Generic Cymbalta – According to a press release from FDA, five companies have been approved to market generic versions of Cymbalta (duloxetine) – a serotonin and norepinephrine reuptake inhibitor (SSRI) that is indicated for major depressive disorder, among other things.  The drug label contains a boxed warning.
  • Agency Announces Antibiotic Plans for Farm AnimalsThis week FDA said it was implementing a plan that would ensure a judicious use of antibiotics in farm animals with the launch of a guidance on the issue.  Because some of the same antibiotics are used in animals as are in humans to treat infection, overuse in the animal population could result in the development of resistant strains.  To address this the agency said that it is laying out a “road map for animal pharmaceutical companies to voluntarily revise the FDA-approved use conditions on the labels of these products to remove production indications” and to bring the OTC status under veterinary oversight.  FDA is asking the companies to notify the agency of their intent to sign on this strategy within the next three months and to then begin a three-year transition process.
  • Final AdComm of the Year – With the conclusion of this week there is only one more Advisory Committee meeting scheduled in 2013.  On December 17, the Risk Communication Advisory Committee will meet to discuss new methods for communication risk information that is part of a Risk Evaluation and Mitigation Strategy (REMS) – a discussion that will include how sponsors and FDA can evaluate the effectiveness of REMS communications.  And speaking of year-end, it was reported this week that FDA has approved 26 new molecular entities this year.

That’s it for me this week folks.  Hope you all have a wonderful weekend.

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