BDX Wins FDA for Ondansetron Injection
BD Rx Inc., a subsidiary of global MedTech company Becton, Dickinson and Company (BDX), has won the U.S. Food and Drug Administration (:FDA) approval for Ondansetron Injection, USP 4mg/2mL (2mg/mL). It is the third drug to be launched in the BD Simplist line of prefilled generic injectables.
Deemed as the future of all injectables, the BD Simplist prefilled injectables are uniquely designed so as to reduce the number of steps in the traditional vial-and-syringe injection sequence from 20 to 12 steps. This lowers the possible risk of medication error, and at the same time, enhances patient safety and clinical outcome.
The Ondansetron Injection, USP, an injectable antiemetic, is used to stop nausea and vomiting, post surgeries. It also has applications in emetogenic cancer chemotherapy. Moreover, the drug is on the FDA shortage list owing to supply scarcity in the U.S. This is clearly indicative of the considerable opportunity that the drug holds of capturing a significant share in the domestic market.
The FDA approval along with the huge demand in the underlying market is expected to boost the company’s sluggish U.S. business. Domestic revenues (contributing 41.3% to total revenues) inched up 1.3% year over year to $848 million in the last reported quarter.
The BD Rx business is an extension of the BDX’s pharmaceutical offerings, a leader in glass prefillable syringe manufacturing. The two other drugs that are already available in the market from the BD Simplist product line include the Metoclopramide Injection, USP and Diphenhydramine Hydrochloride Injection, USP. Given the huge demand for acute care generic injectables, the BD Rx division plans to roll out 20 to 30 more drugs from its BD Simplist line of products within the next few years.
BDX has a Zacks Rank #3 (Hold). While we remain on the sidelines regarding Becton, Dickinson and Company, other medical stocks worth considering include Align Technology (ALGN), The Cooper Companies (COO) and McKesson (MCK). All these stocks carry a Zacks Rank #2 (Buy).
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