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Top related persons:
Patrizia Cavazzoni - 2 Opill - 2 Welgryn - 2  “ - 1 “ - 1 ” - 1 Frederique Welgryn - 1 Perrigo - 1
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4 mentions found


☆ FDA approves first over-the-counter birth control pill
  + stars: | 2023-07-13 | by ( Carma Hassan | ) edition.cnn.com   time to read: +3 min
CNN —The US Food and Drug Administration on Thursday approved the birth control pill Opill to be available over-the-counter — the first nonprescription birth control pill in the United States. Opill is expected to be available over-the-counter in stores by the end of March 2024. The FDA has faced pressure to allow Opill to go over-the-counter from lawmakers as well as health care providers. A recent study showed that it has become harder for women to access reproductive health care services more broadly — such as routine screenings and birth control — in recent years. About 45% of women experienced at least one barrier to reproductive health care services in 2021, up 10% from 2017.
Persons:  “, Patrizia Cavazzoni, “, ”, Frederique Welgryn, Opill, Welgryn, Perrigo, Dr, Sanjay Gupta, —, Meg Tirrell Organizations: CNN, Food and Drug Administration, FDA’s Center, Drug, Research, FDA, CNN Health Locations: United States, U.S
☆ FDA approves Opill, the first over-the-counter birth control pill
  + stars: | 2023-07-13 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +3 min
HRA Pharma expects a final decision by the FDA this summer on its application for nonprescription sales of Opill, which is generically called norgestrel. The Food and Drug Administration on Thursday approved the first over-the-counter birth control pill, a landmark decision that will allow more women and girls in the U.S. to prevent unintended pregnancies without a prescription. The daily pill, called Opill, was first approved by the FDA as a prescription in 1973. Medical organizations like the American College of Obstetricians and Gynecologists and women's health advocates have pushed for wider access. More than 50 members of Congress in March 2022 also called on FDA Commissioner Dr. Robert Califf to ensure the agency reviewed applications for over-the-counter birth control pills without delay.
Persons: Biden, Wade, –, Welgryn, Robert Califf, Patrizia Cavazzoni, Opill Organizations: HRA Pharma, FDA, Drug Administration, American College of Obstetricians, FDA's Center, Drug, Research Locations: U.S, Paris, Dublin
☆ FDA grants full approval to Pfizer Covid treatment Paxlovid for high-risk adults
  + stars: | 2023-05-25 | by ( Annika Kim Constantino | ) www.cnbc.com   time to read: +5 min
The Food and Drug Administration on Thursday granted full approval to Pfizer's Covid antiviral pill, Paxlovid, for adults who are at high risk of getting severely sick with the virus. The FDA first made Paxlovid available in December 2021 under emergency use authorization for high-risk individuals ages 12 and up. Both Pfizer and the FDA view the treatment as an important complementary tool to vaccination that can help high-risk Americans manage their Covid infections and ultimately save lives. For some doctors, another area of concern is Paxlovid "rebound cases." That's when patients who take the treatment see their Covid symptoms return or test positive shortly after they initially recover.
☆ FDA says no indication contaminated cough syrups have entered U.S. supply chain
  + stars: | 2023-03-03 | by ( ) www.reuters.com   time to read: +1 min
March 3 (Reuters) - The U.S. Food and Drug Administration (FDA) said on Friday there was no indication that contaminated cough and paracetamol syrups that caused deaths of children in Gambia last year have entered the U.S. drug supply chain. This comes after an investigation led by the U.S. Center for Disease Control and Prevention and Gambian scientists reported on Thursday that these medicines contaminated with toxic levels of diethylene and ethylene glycol led to acute kidney injury among 78 children in Gambia. "We will continue to monitor the situation and keep the public and health care professionals updated of any changes in status to the U.S. market," Patrizia Cavazzoni, director for FDA's Center for Drug Evaluation and Research, said in a tweet. In October, the World Health Organization sent out an alert saying four cough syrups containing toxic levels of diethylene and ethylene glycol made by India's Maiden Pharmaceuticals Ltd should be withdrawn. Reporting by Mariam Sunny in Bengaluru; Editing by Maju SamuelOur Standards: The Thomson Reuters Trust Principles.
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