Last Updated on January 6, 2024 by The Health Master
Washington: Obstetricians, gynecologists, other medical professionals, and abortion rights advocates petitioned the U.S. Food and Drug Administration (USFDA) to urge Danco Laboratories to seek approval for mifepristone, a pill used in terminating early pregnancies at home, for miscarriage management.
Danco, one of two U.S. companies that make the medicine, said that right now it has no plans to do so.
“At this time, we are not planning to submit (an application) for miscarriage management, but may reconsider in the future,” a spokesperson said. Danco is currently working with the USFDA on changes to where patients can get the drug.
The American College of Obstetricians and Gynecologists (ACOG) asked the USFDA to invite Danco to submit a Supplemental New Drug Application (sNDA) for miscarriage management.
“It is a safe and essential part of the most effective regimen for miscarriage management,” ACOG said.
A USFDA spokesperson said the agency was reviewing the petition and would respond directly to the petitioner.
Mifepristone, in combination with a second drug called misoprostol that has various uses, including miscarriage management, induces an abortion up to 10 weeks into a pregnancy. It is only available through a certified doctor’s prescription.
The combination is more effective for treating an early miscarriage than misoprostol alone, ACOG said in its petition, which was signed by 48 other groups, including the American Medical Association and the American Civil Liberties Union.
Abortion bans have gone into effect in more than a dozen states since the U.S. Supreme Court overturned the constitutional right to terminate pregnancies when it scrapped its landmark 1973 Roe v. Wade ruling on June 24.
Some bans target mifepristone, which limits access to the drug for the purposes of managing a miscarriage because it is only approved to terminate a pregnancy.
NPPA fixes Retail Prices of 40 Formulations: September 2022
USFDA tentative approves Amantadine extended-release capsules
API manufacturing finally getting the attention it deserves
USFDA gives nod for this generic drug for urinary issues
IPC launches 1000th IP Reference Standard
NDPS: Inter-state Pharmaceutical drug racket busted
USFDA issues 2 observations on Form 483 to Zydus Lifesciences
DCGI panel recommends ban on these Fixed dose combination drugs
Drug recall: Acyclovir Sodium Injection recalled due to this reason
Latest Notifications regarding Pharmaceuticals
For informative videos on Hospitals / Doctors, 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:
