Over the Counter Drug Launch Intentions, ANDA Approval

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

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.

Results:

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.

Categories:

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

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