Another month and another report of the approval actions of the Office of Generic Drugs (OGD) for our reader’s review
The FDA issued an update to warnings about use of testosterone replacement products, indicating they are only approved for men with documented medical conditions. FDA stated, “[T]he benefit and safety of these medications have not been established for the treatment of low testosterone levels due to aging, even if a man’s symptoms seem related to low testosterone.”
Like the old joke – How do you eat an elephant? One bite at a time! We are serving up some additional bites at the massive ANDA and 505(b)(2) Proposed Rule. I hope you enjoy your meal!