Tag

Genbiopro

All articles tagged with #genbiopro

healthcare3 years ago•2 min saved

Abortion pill manufacturer sues FDA to preserve access and protect drug.

GenBioPro, the manufacturer of generic mifepristone, has sued the FDA to prevent the drug from being removed from the market. The lawsuit comes on the day that the Supreme Court is expected to rule on whether restrictions should be imposed on the drug, including potentially revoking the generic version's FDA authorization. The company is seeking an order that would require the FDA to keep GenBioPro's mifepristone on the market.

via Axios|

#abortion #fda #genbiopro

politics3 years ago•2 min saved

Generic Abortion Pill Maker Sues FDA to Keep Drug Available.

GenBioPro, the US manufacturer of the generic version of a medication abortion drug, has sued the FDA, alleging that the agency has violated the Constitution’s Due Process Clause and other laws in how it has responded to recent court orders halting the approval of the generic version of the drug, mifepristone. The company is seeking a court order that would require the FDA to go through certain procedural steps laid out under federal law before declaring its mifepristone product unapproved. The Supreme Court is currently considering whether to freeze the court orders that emerged from a separate lawsuit, filed by anti-abortion activists in Texas, that would undo the 2019 approval of the generic version of the drug and reverse other steps the FDA has taken in recent years to make abortion pills easier to obtain.

via CNN|

#abortion #fda #genbiopro

health3 years ago•4 min saved

Abortion pill manufacturer sues FDA to preserve drug access.

GenBioPro, the maker of the generic version of mifepristone, the majority of abortion pills sold in the US, has sued the FDA to protect its drug if courts revoke its approval. The lawsuit is part of the ongoing legal battle over a case filed in federal court in Texas seeking to overturn the FDA's 23-year-old approval of mifepristone. The company seeks to block the FDA from complying if the courts ultimately order mifepristone off the market. The case could have implications for the broader drug industry.

via The New York Times|

#abortion #fda #genbiopro

health3 years ago•1 min saved

Abortion pill manufacturer sues FDA to protect access.

GenBioPro, the maker of the generic version of the abortion pill, has sued the FDA to prevent the agency from rolling back access to the drug if the Supreme Court allows sweeping restrictions to take effect this week. The FDA's 2019 approval of the generic version of mifepristone made by GenBioPro would be suspended if the 5th Circuit Court of Appeals' decision, which endorses much of a challenge brought by the anti-abortion medical group Alliance for Hippocratic Medicine, goes into effect. GenBioPro argues that it has been deprived of its constitutional and statutory rights to market mifepristone without due process of law.

via POLITICO|

#abortion #fda #genbiopro

healthcare3 years ago•2 min saved

Generic abortion pill maker sues FDA to preserve access and protect drug.

GenBioPro, the manufacturer of a generic form of the abortion pill mifepristone, is suing the FDA to preserve access to the drug as anti-abortion rights groups challenge the FDA's approval of the drug. A temporary stay from the Supreme Court preserving access to mifepristone expires today, and if it expires, an order from the 5th U.S. Circuit Court of Appeals would take effect and impose multiple restrictions, including prohibiting the pills from being distributed by mail. GenBioPro's generic form of the drug accounts for about two-thirds of mifepristone sold in the United States.

via NPR|

#abortion #fda #genbiopro