Last Updated on October 11, 2024 by The Health Master
Aurobindo Pharma subsidiary Eugia Pharma Specialties has received the final approval from the U.S. Food and Drug Administration (USFDA) to manufacture and market Carboprost Tromethamine Injection USP 250 mcg/mL, single-dose vials.
Bioequivalent and therapeutically equivalent to Pfizer’s Hemabate Injection, 250mcg/mL, the reference listed drug, it is expected to be introduced in June.
The approved product has an estimated market size of about $51.4 million for the 12 months ending March 2023, Aurobindo said citing IQVIA numbers.
The product is indicated for aborting pregnancy between the 13th and 20th weeks of gestation and for the treatment of postpartum haemorrhage due to uterine atony.
This is the 159th approved ANDA, including eight tentative approvals received, out of Eugia Pharma Specialty Group (EPSG) facilities, manufacturing both oral and sterile specialty products, the company said.
USFDA gives final approval for Ephedrine Sulfate Injection
USFDA gives approval for Brexpiprazole
USFDA gives approval for Pupil-dilating spray
USFDA gives approval for this first RSV Vaccine
USFDA gives tentative nod for ARV oral, Dolutegravir
USFDA gives approval for next generation Pneumococcal Vaccine
Medical device packs will have to display key information
IDMA proposes additional cost allowance for QR Code implementation
HM launches National Medical Device Policy 2023, read details
Medical Device alert: CDSCO issues alert on these Intra Ocular Lens
Himachal Pradesh: 11 Pharma companies told to shut operations
Difference between Validation and Calibration in the Pharma Industry
DPCO 2013: Pharma Industry urges Govt to revisit Para 18(1) and para 13(2)
Govt amends guidelines for Promotion of Medical Device Parks Scheme
Govt to amend Cosmetics Rules 2020 to strengthen Regulation & Quality control
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
