Full Press Release Details
Pharmaceuticals and XGen Pharmaceuticals DJB Announce Commercial Launch of Rezipres (ephedrine hydrochloride), a Ready-to-Use Formulation
of Injectable Ephedrine (4.7 mg/mL)
PARK, Ill., Mar. 14, 2022 (GLOBE NEWSWIRE) - Eton Pharmaceuticals, Inc. (Nasdaq: ETON) and XGen Pharmaceuticals DJB, Inc. today
announced the commercial availability of Rezipres (ephedrine hydrochloride) injection. Rezipres (4.7 mg/mL) is a ready-to-use1
formulation of injectable ephedrine hydrochloride that is approved for the treatment of clinically important hypotension occurring
in the setting of anesthesia.
are excited to announce yet another new product launch. The availability of Rezipres will provide hospitals with an FDA-approved, ready-to-use
ephedrine injection product as an alternative to compounded formats which are not approved by the FDA. We look forward to partnering
with XGen DJB given their extensive track record of successfully commercializing injectable products in the hospital setting,"
said Sean Brynjelsen, CEO of Eton Pharmaceuticals.
are delighted to be teaming up with Eton as the commercial partner in introducing their ready-to-use Rezipres product, which is the first
FDA-approved hydrochloride-based ephedrine injectable formulation," added Edmund Vanderbeck, President of XGen Pharmaceuticals
DJB. "This product will provide doctors with a new option in treating clinically important hypotension occurring in the setting
DJB's seasoned hospital sales force will be responsible for commercializing the product, and Eton will continue to retain ownership
of the product's New Drug Application on file with the FDA.
on IQVIA data, the market for ephedrine injections grew 24% in 2021 to $86 million and 5.9 million units, up from $69 million and 4.7
million units in 2020.
is being made available in a 5mL ampule with a strength of 23.5mg/5mL (4.7 mg/mL), equivalent to 19mg/5mL (3.8 mg/mL) ephedrine base.
The product can be stored at room temperature and does not contain any preservatives or sulfites. The product is now available for ordering
through wholesalers McKesson, AmerisourceBergen, and Cardinal Health. For additional ordering and product information, visit www.xgenpharmadjb.com.
Rezipres (ephedrine hydrochloride)
(ephedrine hydrochloride) is an alpha- and beta-adrenergic agonist and a norepinephrine-releasing agent that is indicated for the treatment
of clinically important hypotension occurring in the setting of anesthesia.
| Serious postpartum hypertension can occur in patients also receiving both a vasopressor and an oxytocic. Some patients experienced a stroke. | |
| Repeated administration of ephedrine can result in tachyphylaxis. An alternative pressor may be needed to mitigate unacceptable responsiveness. | |
| When used to prevent hypotension, ephedrine can cause an increased incidence of hypertension compared to when used to treat hypotension. |
common adverse reactions during treatment: nausea, vomiting, dizziness, restlessness, palpitations, tachycardia, reactive hypertension,
bradycardia, ventricular ectopics, and R-R variability. To report SUSPECTED ADVERSE REACTIONS, contact Eton Pharmaceuticals at
855-224-0233 or FDA at 1-800-FDA-1088.
| Agonistic Effects (increase in Rezipres blood pressure effect) can occur with clonidine, oxytocin and oxytocic drugs, monoamine oxidase inhibitors (MAOI), and atropine. | |
| Antagonistic Effects (decrease in Rezipres blood pressure effect) can occur with -adrenergic antagonists, -adrenergic antagonists, reserpine, quinidine, mephentermine. | |
| Inhibition of the neuron blockage produced by guanethidine can occur resulting in loss of antihypertensive effectiveness. | |
| Reduction in the onset time of neuromuscular blockade can occur when used for intubation with rocuronium if administered simultaneously with anesthetic induction. | |
| The efficacy of epidural blockade can be decreased by hastening the regression of sensory analgesia. | |
| Concomitant use of theophylline may increase the frequency of nausea, nervousness, and insomnia. | |
| Concomitant use of a cardiac glycoside, such as digitalis, may increase the possibility of arrhythmias. |
more information, please see Rezipres Full Prescribing Information at www.xgenpharmadjb.com.
[Package Insert]. Deer Park, IL: Eton Pharmaceuticals; 2022
Eton Pharmaceuticals
Pharmaceuticals, Inc. is an innovative pharmaceutical company focused on developing and commercializing treatments for rare diseases.
The company currently owns or receives royalties from six FDA-approved products, including ALKINDI SPRINKLE , Carglumic Acid, Biorphen ,
Alaway Preservative Free, Rezipres , and Eprontia , and has four additional products that have been submitted to the FDA.
About XGen Pharmaceuticals DJB
Pharmaceuticals DJB, Inc. is a family-owned pharmaceutical company spanning three generations, located in Horseheads, New York with a
50-year tradition in the pharmaceutical industry.. XGen DJB is extraordinarily proud to be woman-owned and operated, holding the National
Women's Business Enterprise Certification (NWBEC). Building on our legacy of success, XGen DJB's primary focus is in forging
rich and lasting partnerships that enhance and accelerate the development, manufacture and delivery of specialty pharmaceutical products,
creating improved patient access and outcomes. XGen DJB's portfolio centers on acute care, critical need injectable products targeted
to the hospital, clinical and specialty markets, predominantly focused on meeting US demand.
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