FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products


BD Rx Inc., a wholly owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company), recently announced the US FDA has approved the third drug to be offered in the new BD Simplist line of ready-to-administer prefilled generic injectables. The third BD Simplist product to launch is Ondansetron Injection, USP 4mg/2mL (2mg/mL), an injectable antiemetic.

Ondansetron Injection, USP, which is used to prevent postoperative nausea and vomiting, is currently on the FDA drug shortage list due to recent demand increases and supply issues faced by other manufacturers. Ondansetron Injection, USP also can be used with initial and repeat courses of emetogenic cancer chemotherapy.

“We’re proud to be expanding our BD Simplist products with a drug like Ondansetron Injection, USP, which is in high demand among clinicians and fills a need for an intervention that can be administered quickly,” said Mark Sebree, President, BD Rx. “As we establish our product line with a third drug approval, we are seeing even further indication of the positive response to our new BD Simplist prefilled injectables especially among repeat customers.”

In March, BD announced that it would be manufacturing generic pharmaceutical products for the first time through BD Rx. BD Rx also manufactures Metoclopramide Injection, USP and Diphenhydramine Hydrochloride Injection, USP within the BD Simplist prefilled injectables line of products. BD Simplist prefilled injectables are designed to help improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence, reducing the potential risk of medication error.

The potential for medication error exists with every injection. Clinicians perform up to 20 steps in a traditional vial and syringe injection sequence. But with BD Simplist prefilled injectables, the injection sequence is reduced to approximately 12 steps, reducing the potential risk of medication error and allowing for more focus on the patient and less on injection preparation.

BD Rx plans to launch 20 to 30 drugs in its BD Simplist line of products during the next few years and is targeting generic injectables in doses most commonly relied on by clinicians in both the hospital and surgical center settings.

BD is a leading global medical technology company that develops, manufactures, and sells medical devices, instrument systems, and reagents. The company is dedicated to improving people’s health throughout the world. BD is focused on improving drug delivery, enhancing the quality and speed of diagnosing infectious diseases and cancers, and advancing research, discovery, and production of new drugs and vaccines. BD’s capabilities are instrumental in combating many of the world’s most pressing diseases. For more information, visit www.bd.com.