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US FDA approves second drug in BD Simplist prefilled injectable line of products
Franklin Lakes, New Jersey | Thursday, April 25, 2013, 17:00 Hrs  [IST]

The US Food and Drug Administration (FDA) has approved the BD Rx Inc's, a wholly-owned subsidiary of BD (Becton, Dickinson and Company), second drug to be offered in the recently launched BD Simplist line of ready-to-administer prefilled generic injectables. The second BD Simplist product to launch is Metoclopramide Injection, USP, an injectable antiemetic.

BD Rx launched its first drug – BD Simplist Diphenhydramine Hydrochloride Injection, USP, an injectable antihistamine – on March 27, 2013. 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.

“After a successful launch of BD Simplist prefilled injectables, we’re excited to be coming out with a second drug that is commonly used by clinicians. This is just the beginning of our new line of prefilled injectable products,” said Mark Sebree, president, BD Rx. “BD has a long-standing reputation for delivering high-quality, high-volume products. Our work at BD Rx is no different, as we bring that same commitment to quality and patient safety to our new work in generic drug manufacturing.”

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.

The company 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 centre settings.

Metoclopramide injection, USP is indicated for the relief of symptoms associated with acute and recurrent diabetic gastric stasis, prophylaxis of vomiting associated with emetogenic cancer chemotherapy and the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Diphenhydramine Hydrochloride Injection, USP is effective in adults and paediatric patients, other than premature infants and neonates, when diphenhydramine hydrochloride in the oral form is impractical.

For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine  and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. For active treatment of motion sickness and for use in parkinsonism, when oral therapy is impossible or contraindicated in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents.

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.

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