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

FRANKLIN LAKES, N.J., Aug. 29, 2013 /PRNewswire/ -- BD Rx Inc., a wholly-owned subsidiary of leading global medical technology company BD (Becton, Dickinson and Company) BDX, announced today that the U.S. Food and Drug Administration (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.^1,2 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.

About Ondansetron Injection, USP 4mg/2mL (2mg/mL)
INDICATIONS
Ondansetron Injection is a 5-HT₃ receptor antagonist indicated for:
Prevention of nausea and/or vomiting postoperatively and with initial and repeat courses of emetogenic cancer chemotherapy.

IMPORTANT SAFETY INFORMATION
Ondansetron Injection is contraindicated in patients know to have hypersensitivity (e.g. anaphylaxis) to this product or any of its components and in the concomitant use of apomorphine.

Hypersensitivity reactions including anaphylaxis and bronchospasm have been reported in patients who have exhibited hypersensitivity to other selective 5-HT₃ receptor antagonists.  QT prolongation occurs in a dose-dependent manner.  Torsades de Pointes have been reported.  Avoid Ondansetron in patients with congenital long QT syndrome.  Use in patients following abdominal surgery or in patients with chemotherapy-induced nausea and vomiting may mask a progressive ileus and/or gastric distention.

The most common adverse reactions in adults are headache, diarrhea and fever.  In pediatric patients (ages 1 to 24 months), the most common adverse reaction is diarrhea.

For additional important safety information, please see the Ondansetron full prescribing information.

About Metoclopramide Injection, USP
INDICATIONS AND USAGE 
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
• the prophylaxis of postoperative nausea and vomiting in those circumstances where nasogastric suction is undesirable.

Metoclopramide Injection, USP also may be used to:

• facilitate small bowel intubation in adults and pediatric patients in whom the tube does not pass the pylorus with conventional maneuvers
• stimulate gastric emptying and intestinal transit of barium in cases where delayed emptying interferes with radiological examination of the stomach and/or small intestine.

IMPORTANT SAFETY INFORMATION

• Metoclopramide treatment can cause tardive dyskinesia, a serious movement disorder that is often irreversible. Therapy should be discontinued in patients who develop signs or symptoms of tardive dyskinesia. Treatment for longer than 12 weeks should be avoided in all but rare cases.
• Metoclopramide is contraindicated whenever stimulation of gastrointestinal motility might be dangerous; in patients with pheochromocytoma; in patients with epilepsy or taking drugs which are likely to cause extrapyramidal reactions; or patients with known sensitivity or intolerance to the drug.
• Metoclopramide can cause serious side effects including abnormal muscle movements, uncontrolled spasms of the face and neck muscles, or muscles of the body, arms, and legs, depression, thoughts of suicide, and suicide, and rarely but serious Neuroleptic Malignant Syndrome and Parkinsonism.
• The most common side effects of Metoclopramide Injection include feeling restless, sleepy, tired, dizzy, or exhausted, headache, confusion and trouble sleeping.

For additional Important Safety Information, please see the metoclopramide full prescribing information including BOXED WARNINGS and Medication Guide.

About Diphenhydramine Hydrochloride Injection, USP
INDICATIONS AND USAGE
Diphenhydramine Hydrochloride Injection, USP is effective in adults and pediatric 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.

IMPORTANT SAFETY INFORMATION
Diphenhydramine hydrochloride is contraindicated in neonates, premature infants, and as antihistamine therapy in nursing mothers and as a local anesthetic and when a patient is hypersensitive to other antihistamines of similar chemical structure.

Considerable caution should be used in patients with narrow-angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, symptomatic prostatic hypertrophy, or bladder-neck obstruction.

Local necrosis has been associated with the use of subcutaneous or intradermal use of the drug. It has an atropine-like action and, therefore should be used with caution in patients with a history of bronchial asthma, increased intraocular pressure, hyperthyroidism, cardiovascular disease or hypertension and in patients with lower respiratory disease including asthma.

It has additive effects with alcohol and other CNS depressants. MAO inhibitors prolong and intensify the anticholinergic (drying) effects of antihistamines.

The most frequent adverse reactions are: Nervous System: sedation, sleepiness, dizziness, disturbed coordination; GI System: epigastric distress; and Respiratory System: thickening of bronchial secretions

Please see full prescribing information for additional important safety information.

About BD
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. Founded in 1897 and headquartered in Franklin Lakes, New Jersey, BD employs nearly 30,000 associates in more than 50 countries throughout the world. The Company serves healthcare institutions, life science researchers, clinical laboratories, the pharmaceutical industry and the general public. For more information, please visit www.bd.com.

References

1. Ondansetron PI.
2. U.S. Food and Drug Administration. Current Drug Shortages Index. Available at http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm314742.htm and viewed on July 18, 2013.

Contact:
Alyssa Zeff
Public Relations
(201) 847-4358
Alyssa_Zeff@bd.com

 

SOURCE BD-Becton Dickinson