Over the Counter Drug Launch Intentions, ANDA Approval

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Project ThumbOver the Counter Drug Launch Intentions, ANDA Approval
Top 10 Generic Manufacturer, OTC Division

Our client needed to know a competitor’s intentions towards launching a generic version of a popular allergy drug, which was about to make an Rx-to-OTC switch. Due to peculiarities in the FDA approval process, the status of the competitor’s ANDA was unknown and was holding up our client’s ability to launch — a potentially expensive proposition given that our client had already begun to manufacturer the product. Relying on a variety of sources, VOI was able to determine the status of the competitor’s application.


VOI provided information that was used by the client’s legal team to move their tentatively approved ANDA to full approval status. As a result, our client was able to launch on time and to ship their accumulated inventory without loss.


Competitive intelligence, Rx-to-OTC switch, FDA approval, store brand OTC, cough-cold-allergy drugs.

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