QDIS Blog

A blog about chemistry, drug development, science, and technology

August 18, 2006

Barr Labs to Resubmit Plan B OTC Application

by @ 9:36 am.  Filed under Health News, FDA, Pharma News

This very short article today is interesting.

Barr refiles morning-after pill bid, FDA says - Yahoo! News:

Barr will re-file its application to sell Plan B. No details were made public and nothing was said about why or what may be different. My best guess is that Barr i going to change the age from 16 to 18 since the FDA has basically state that they would support that. Also, they will likely be submitting new packaging for the over-the-counter product in order to readily differentiate it from the prescription version.

Another interesting aspect will be how different the two version need to be. Will just different packaging be enough? I am curious if the topic of making the pill a different shape or color will come up. This would most likely further delay the approval. Given how things have gone in the past, this would not surprise me.

Another interesting item is that this announcement is not yet on Barr’s website. Maybe they are keeping their head low to avoid further publicity.

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Email Ed Vawter



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