Last Updated on October 6, 2024 by The Health Master
Aurobindo Pharma’s wholly owned subsidiary, Eugia Pharma Specialties, has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Medroxyprogesterone Acetate Injectable Suspension USP, 150 mg/mL, 1 mL single-dose vial.
The approved product is bioequivalent and therapeutically equivalent to the reference listed drug, Pfizer’s Depo-Provera Injectable Suspension.
Medroxyprogesterone Acetate Injection is indicated for use by females of reproductive potential to prevent pregnancy, the drugmaker said.
The product will be unveiled in the third quarter of FY23. The approved product has an estimated market size of about $62 million for the 12 months ending June 2022, Aurobindo Pharma said, citing IQVIA numbers.
The pharma major said this was the 147th ANDA, including 10 tentative approvals received, out of Eugia Pharma Speciality Group facilities, manufacturing both oral and sterile specialty products.
Aurobindo shares remained flat, gaining less than 1% on the BSE to close at 560.35 apiece on Wednesday.
USFDA gives nod for Formoterol Fumarate inhalation solution
USFDA gives nod for generic Carbamazepine tablets
USFDA gives approval for this BP monitor device
USFDA gives nod for generic Naproxen Sodium Softgel Capsules
USFDA gives approval for Rufinamide tablets
USFDA approves generic Vasopressin injection
This Air is an essential element for the Tablet Coating Process
USFDA gives nod for Formoterol Fumarate inhalation solution
NPPA fixes Retail Prices of 45 drug formulations
CDSCO panel wants justification on Protocol Amendments on Trail of Imlunestrant
USFDA gives nod for generic Carbamazepine tablets
FDA fixes upper limit for Wholesalers & Retailers for storage, sale of NDPS DRugs…
Govt revises guidelines for PLI scheme domestic Medical Devices
Nicotine replacement therapy may become part of Essential Medicines List
Drug recall: Glenmark, Strides Pharma, Cipla recalled these drugs
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
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:
