FDA Approves Third Drug in BD Simplist Prefilled Injectable Line of Products
FDA approves BD Simplist product ondansetron injection, an injectable antiemetic.
BD Rx, a subsidiary of BD, reports that FDA has approved a third drug to be offered in the BD Simplist line of prefilled generic injectables. The third BD Simplist product to launch is ondansetron injection, US Pharmacopeia (USP) 4 mg/2 mL (2mg/mL), an injectable antiemetic.
Ondansetron injection, 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. The product can be used with initial and repeat courses of emetogenic cancer chemotherapy.
In March, BD announced that it would be manufacturing generic pharmaceutical products for the first time through it subsidiary BD Rx. BD Rx also manufactures metoclopramide injection, and diphenhydramine hydrochloride Injection, USP within the BD Simplist prefilled injectables line of products. BD Simplist prefilled injectables are designed to decrease the number of steps in the traditional vial and syringe injection sequence, thereby reducing the potential risk of medication error.
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.
Source: BD Rx
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