Jubilant Radiopharma Radiopharmacies Division PET Drugs Earn FDA Approval

While we, as consumers, may often think that the process and timeframe necessary to get a pharmaceutical agent approved is overly extensive, the FDA's Center for Drug Evaluation and Research (CDER) drug development and approval process is designed with one goal in mind: to keep Americans safe.

Before a drug, either brand name or generic, is approved for use in humans, the Center ensures that it works correctly and that its health benefits outweigh any associated risks. In the words of CDER, this evaluation process "not only prevents quackery, but also provides doctors and patients the information they need to use medicines wisely."

Such diligence is particularly essential in this era of unscrupulous "copy-cat" drug manufacturers, who market and distribute radiopharmaceutical preparations that are not FDA-approved for human use. Unfortunately, as has been well documented via this blog series, the nuclear medicine industry is not immune to this concerning trend. (For more information, see Jubilant Radiopharma Radiopharmacies Division's Industry Insider Blog posts from May and July of 2015.)

Recognizing the significance of the FDA's thorough process, Jubilant Radiopharma Radiopharmacies Division was particularly pleased during the past several months to announce not one but two approvals by the FDA of our Abbreviated New Drug Applications: the first, for Fludeoxyglucose F18 (18F FDG), in August; and the second, for Sodium Fluoride F-18 Injection for Intravenous Use, in November. These FDA stamps of approval are particularly meaningful to our company, which guarantees customers that we procure and supply only FDA-approved radiopharmaceutical products exclusively from FDA-approved cGMP compliant manufacturers. In fact, we can now amend that statement to read: Jubilant Radiopharma Radiopharmacies Division procures, supplies and manufactures only FDA-approved radiopharmaceutical products!

Though abbreviated in its requirements, the ANDA process is necessary to gain FDA-approval of a generic drug product is equally important. Generic applicants must scientifically demonstrate that their product is bioequivalent to the originator drug. In other words, it performs in the same manner and ensures the same level of patient safety as the original product evaluated by CDER.

PET products are available through Jubilant Radiopharma Radiopharmacies Division pharmacies located in Atlanta and Macon, GA, and Mobile, AL, which serve customers throughout the southeastern United States. For more information about PET agents available through Jubilant Radiopharma Radiopharmacies Division, contact your local Director of Sales.

Note: Important Safety Information is available through the following links: ISI for FDG and ISI for Sodium Fluoride.