Generics

This edition of the Proposed Rule saga covers a few more interesting issues. The rule-which was 11 years in the making (longer than the final Hatch-Waxman rule on the patent and exclusivity provisions of the Act, which was10 years in the making) really tightens up some of the long-established practices of the Agency and explains why the FDA is taking the actions that it is. Makes for good reading, but make sure you have your toothpicks ready to prop open your eyes. We are just through page 120 of the 300+ pages.

The ANDA and 505(b)(2) Proposed Rule, that (due to its length) we like to call Moby Dick, addresses a plethora of issues of importance to the generic industry, and we are trying to tackle many of them in multiple posts. This is a continuation of that effort.

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!

The Office of Generic Drugs (OGD) just released its January productivity numbers and there are some interesting observations to share.

Here are some more tidbits gleaned from the Proposed Rule, and a correction regarding a previous post.

As we continue our march through the 371 page document, as something piques our interest we will provide you with a bit of a summary along with some background. Here are today’s tidbits!