Nexium Without a Prescription? New Prescription to OTC Drug Approval

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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Recently, you may have noticed several medications available in the store aisles that used to require a prescription. A few drugs have made the jump from prescription-only to being sold over-the-counter (OTC) without a prescription, with Nexium as the newest (and a very exciting) example.

The status change for Nexium 20 mg capsules was approved by the FDA on March 28th, 2014. Nexium is used mainly for the treatment of gastrointestinal esophageal reflux disease (GERD), better known as acid reflux or heartburn. It will be sold over-the-counter as Nexium 24HR.

Nexium will still be available by prescription in various forms and strengths, including some that will not be available without a prescription. This may be helpful if your insurance will cover it, but if you’re paying out of pocket or have a high deductible, the OTC version will be significantly less expensive.

You can find more information regarding the status change of Nexium 24HR here.

So, what is the difference between the prescription and the OTC version of a drug like Nexium?

You should know that before the status of these medications can be changed, the FDA requires that they are evaluated for both safety and efficacy, so the OTC version is just as safe and effective.

Having medications available without a prescription gives you the liberty to decide which medication you think will be right to help you and treat your specific symptoms, and may be more convenient and less expensive.

Typically, the medications that are available over-the-counter treat conditions that do not require extra monitoring or follow-up with a healthcare provider and thus can be used at your discretion, but it is important to follow directions and ask your pharmacist or doctor if you have any questions or concerns.

How is the decision made to switch a medication from prescription to OTC?

A manufacturer must decide to submit a New Drug Application or NDA to the FDA to switch a prescription product to an over-the-counter product. The FDA will then review the application to determine if the medication has a comprehensive safety profile and decide if labeling can be developed so that it can be sold safely and effectively as an over-the-counter medication.

What are some other recent prescription to OTC switches?

One of the newest medications to change its status from prescription-only to OTC is Nasacort AQ (sold without a prescription as Nasacort Allergy 24HR). Nasacort treats nasal congestion, sneezing and itchy or runny nose. You can also still get the generic, triamcinolone acetonide 55mcg, from the pharmacy with a valid prescription from your doctor. You can find more information and a coupon for Nasacort Allergy 24HR here.

Another new OTC medication is Oxytrol for Women, a topical patch used for the treatment of overactive bladder in women 18 and older. You can find more information on Oxytrol for Women here.

Over the last few years there have been several more medications that have made the move from behind the pharmacy counter into the aisles of your pharmacies and grocery stores, including: Allegra, Zyrtec, Prilosec OTC, Prevacid 24HR, Plan B One-Step, Miralax, Alli, and Pepcid AC.

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