Subject: FDA
American Regent Announces the FDA Approval of Hydroxyprogesterone Caproate Injection, USP; the First Preservative Free, AP Rated Generic to Makena®*(1)
SHIRLEY, N.Y., June 28, 2018 /PRNewswire/ -- American Regent today announced the launch of Hydroxyprogesterone Caproate Injection, USP, the only preservative free generic alternative to Makena®.
Hydroxyprogesterone Caproate Injection, USP is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. "The approval of this preservative free, generic alternative represents our commitment to ensuring both patients and providers have access to additional, affordable treatment options for this women's health concern," said Ken Keller, President and CEO of American Regent, Inc.
Hydroxyprogesterone Caproate Injection, USP is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Hydroxyprogesterone Caproate Injection, USP will be available in a 250 mg/mL, 1mL preservative free Single Dose Vial and can be ordered through wholesalers/distributors within the next several days. Customers may also contact our Customer Support Group at 1-800-645-1706. For additional ordering or stocking information, please contact Jeremy Tatum at 631-565-0819.
Hydroxyprogesterone Caproate Injection, USP is supplied as follows:
|
NDC# |
Strength |
Supplied As |
Shelf Pack |
|
0517-1767-01 |
250 mg/mL |
1 mL SDV |
1 |
*Makena® is a trademark of AMAG Pharma USA, Inc.
See the Full Prescribing Information in the related documents section and at www.americanregent.com
Reference: 1. Approved Drug Products with Therapeutic Equivalence Evaluations.
https://www.accessdata.fda.gov/scripts/cder/ob/results_product.cfm?Appl_Type=A&Appl_No=210723. Accessed June 2018
About American Regent
American Regent is a leader in the development, manufacturing and sales of generic and branded IV products. With a history of 50 years in generic specialty injectables, American Regent has sales approaching one billion dollars.
American Regent strives for continuous improvement to bring to market high quality innovative medications to meet unmet medical needs, and produces high quality accessible generic medications covering a wide array of therapeutic areas. American Regent is a member of the Daiichi Sankyo Group; and is headquartered in Shirley, NY.
For more information, please visit americanregent.com.
About Daiichi Sankyo
Daiichi Sankyo is a global pharmaceutical company with corporate origins in Japan. We provide innovative products and services in more than 20 countries around the world. With more than 100 years of scientific expertise, our company draws upon a rich legacy of innovation and a robust pipeline of promising new medicines to help patients.
Through the outstanding knowledge and commitment of our 15,000 employees worldwide, we create innovative new and generic medicines, and new methods of drug discovery and delivery. We share a passion for innovation, as well as compassion for the patients around the world who are in need of our medicines.
For more information, please visit: www.daiichisankyo.com. Daiichi Sankyo, Inc., headquartered in Basking Ridge, New Jersey, is a member of the Daiichi Sankyo Group. For more information on Daiichi Sankyo, Inc., please visit: www.dsi.com.
Harsher Singh
Vice President and Chief Commercial Officer
Phone: 631-924-4000
[email protected]
SOURCE American Regent
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