Introduction FDA is charged with the duty of regulating the manufacture, sale and distribution of both prescription drugs and nonprescription drugs (aka over-the-counter or OTC medications).[1] A significant FDA role in the regulation of these medications is supporting sponsors in their efforts to ensure adequate drug product labeling. In this paper, we will describe the…
In case you need a regulatory refresher, the Request for Designation is the formal process to determine which Center will conduct premarket review and regulate a combination product (See Guidance for Industry Office of Combination Products April 2011: How to Write a Request for Designation). Recently, FDA announced through FDAVoice that changes to the program…
FDA recently approved another Rx-to-OTC switch. Formerly available by prescription only, Veramyst® will now be known for the purpose of OTC marketing as Flonase® Sensimist™ Allergy Relief (fluticasone furoate, 27.5 mcg spray). Sensimist™ (NDA 022051/S-013) is approved to treat symptoms associated with seasonal and perennial allergies. Read the full story here. The path to the…
FDA recently announced on FDAVoice that they plan to facilitate ways to encourage industry to submit an NDA for an Rx-to-OTC switch. The announcement directly addresses prescription naloxone, indicated for treatment of opioid overdose. This unusual step is consistent with FDA’s opioid action plan and is aimed at making the drug more widely available. To…