Capstone Announces FDA Approval and EU Authorization of Doxorubicin Hydrochloride Liposome Injection
14 Dec 2022
Drug Approval
ROSEMONT, Ill., Dec. 14, 2022 /PRNewswire/ -- Capstone Development Services Company LLC ("Capstone") announced today that it has received approval from the U.S. Food and Drug Administration (FDA), as well as authorization from the European Commission for doxorubicin hydrocholoride liposomal injection. Authorized as a treatment for multiple types of cancer, the product was developed by Capstone in partnership with a leading medical products company.
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Doxorubicin Hydrochloride Liposome Injection is indicated for treatment of ovarian cancer, acquired immune deficiency syndrome (AIDS)-related Kaposi's Sarcoma and multiple myeloma. It also is authorized in the EU for treatment of metastatic breast cancer. The product is an anthracycline topoisomerase inhibitor encapsulated in liposomes for intravenous use.
These approvals are a testament to our team's expertise in complex formulations. - Dan Robins, Ph.D., president, Capston
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The authorizations mark the 19th and 20thth regulatory approvals Capstone has gained for products developed since its founding in 2013. Capstone funded, developed and led the regulatory approval process of the product. After gaining approvals, it transferred ownership of the product to its medical products partner.
Dan Robins, Ph.D., president, Capstone, said:
"These approvals are a testament to our team's expertise in complex formulations. We are thrilled to have led the development and regulatory process to bring this important product to market on behalf of our global partner."
For more details about doxorubicin hydrocholoride liposomal injection, including the boxed warning for cardiomyopathy and infusion-related reactions, see full prescribing information.
Doxorubicin Hydrochloride Liposome Injection
, USP Important Safety Information
WARNING
Doxorubicin hydrochloride liposomal infusion can cause myocardial damage, including acute left ventricular failure. The risk of cardiomyopathy was 11% when the cumulative anthracycline dose was between 450mg/m2 to 550mg/m2. Assess left ventricular cardiac function prior to initiation of doxorubicin hydrochloride liposomal infusion, during treatment, and after treatment.
Serious, life-threatening, and fatal infusion-related reactions can occur. Acute infusion-related reaction occurred in 11% of patient with solid tumors. Withhold doxorubicin hydrochloride liposomal infusion for infusion-related reactions and resume at a reduced rate. Discontinue doxorubicin hydrochloride liposomal infusion for serious or life-threatening infusion-related reactions.
About Capstone
Capstone was founded in 2013 by Water Street Healthcare Partners, a strategic investor focused exclusively on health care. The company leads development, manages regulatory services and achieves timely approval of health care products through partnerships with global pharmaceutical and medical companies. To date, Capstone has developed and gained regulatory approvals on 20 products in the U.S., EU and Canada. The company supports its partners with bringing new and affordable health care products to market. For more information, visit capstonedevservices.com.
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