BD Gets the Point WIth Third US FDA Approval
BD entered the pharma manufacturing business in March with the launch of its Simplist line of generic injectables tow of which - Metoclopramide and Diphenhydramine Hydrochloride Injections - were already approved by the US FDA.
Now five months on the agency has approved BD’s Ondansetron Injection, which is used to prevent postoperative nausea and vomiting.
“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,” said Sebree, President of BD Rx, BD’s wholly-owned subsidiary.
According to Sebree back in March, all BD’s drugs are manufactured from its newly built facility in Wilson, North Carolina. He told this publication BD chose to build a facility from scratch in order “to be compliant with the highest standards possible.”
Ondansetron is an injectable antiemetic which is currently on the US FDA’s drug shortage list due to an increase in demand and supply issues.
According to the list, problems with shipping delays have affected Pfizer’s supply, whilst recent requirements relating to compliance with good manufacturing practices (GMP) has affected supply from Wockhardt.
Syringe business
News of the approval comes a few months after BD launched its Neopak Glass Prefillable Syringe. At the time the firm said that the product is designed to cater for growing biopharmaceutical industry demand for technologies capable of deliverying larger more complex therapeutic molecules.
Amanda Davis – Senior Product Manager at BD Medical – told in-Pharmatechnologist.com that: “The biotechnology market along with regulatory agencies have set very specific requirements for drug delivery of biologics in terms of quality, safety and functionality that surpass requirements from even five years ago.”
