Rx-to-OTC Switch? Consult PDG!

A successful campaign to switch a drug from prescriptions status to over-the-counter can open up huge new market potential

The U.S. market for OTCs more than doubled between 2007 and 2013, growing from $16 billion to $33 billion. By 2014, an estimated 240 million Americans were using OTC medicines.

Yet, FDA regulatory pathways can be fraught with peril.

Or, perhaps you are concerned with battle-for-shelf-space marketing challenges.

Should You Make the Switch?

PDG is experienced in helping pharmaceutical companies navigate the process of transitioning Rx drug products to over-the-counter.

If your drug can be a safe and effective treatment for easily self-diagnosed ailments and you would like to take advantage of expanding its market exponentially, we can help you validate your thinking.

PDG has years of experience assisting clients demonstrate adequate self-diagnosis and safe, self-treatment with potential OTC drugs. Then using the FDA 505(b)(2) pathway, successfully transition that prescription drug product to over-the-counter and to many more users’ medicine cabinets.

Call +1.813.419.PDG1 (7341) or submit the form below, to explore how PDG can help navigate the FDA Rx-to-OTC maze.

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