By: IPP Bureau
Last updated : May 27, 2023 10:10 am
The product is expected to be launched in June 2023
Aurobindo Pharma Limited has announced that its wholly owned subsidiary company, Eugia Pharma Specialties Limited, has received a final approval from the US Food & Drug Administration (USFDA) to manufacture and market Carboprost Tromethamine Injection USP 250 mcg/mL, Single-Dose Vials, which is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Hemabate Injection, 250mcg/mL, of Pfizer.
The product is expected to be launched in June 2023. The approved product has an estimated market size of around US$51.4 million for the twelve months ending March 2023, according to IQVIA.
This is the 159th approved ANDA (including 8 tentative approvals received) out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products.
It is indicated for aborting pregnancy between the 13th and 20th weeks of gestation as calculated from the first day of the last normal menstrual period and in the following conditions related to second trimester abortion:
Failure of expulsion of the fetus during the course of treatment by another method.
Premature rupture of membranes in intrauterine methods with loss of drug and insufficient or absent uterine activity.
Requirement of a repeat intrauterine instillation of drug for expulsion of the fetus.
Inadvertent or spontaneous rupture of membranes in the presence of a previable fetus and absence of adequate activity for expulsion.
Carboprost Tromethamine injection is indicated for the treatment of postpartum hemorrhage due to uterine atony which has not responded to conventional methods of management. Prior treatment should include the use of intravenously administered oxytocin, manipulative techniques such as uterine massage and, unless contraindicated, intramuscular ergot preparations.
Studies have shown that in such cases, the use of Carboprost Tromethamine injection has resulted in satisfactory control of hemorrhage, although it is unclear whether or not ongoing or delayed effects of previously administered ecbolic agents have contributed to the outcome.
In a high proportion of cases, Carboprost Tromethamine injection used in this manner has resulted in the cessation of life- threatening bleeding and the avoidance of emergency surgical intervention.