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Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. The FDA pulled up these companies for failing to establish processes to ensure infant formula does not become contaminated during manufacturing. The recalls were meant to remove products potentially contaminated with the bacteria cronobacter sakazakii, the FDA added. "The agency... believes that the recalls were effective in removing the potentially contaminated batches of product from the market," the FDA said. Infant formula manufacturing is under greater scrutiny following the shortage of the product last year due to a shutdown of Abbott Laboratories' (ABT.N) unit in Michigan.
Persons: Andrew Kelly, Benckiser, Mead Johnson, Perrigo, ByHeart, Leroy Leo, Krishna Chandra Organizations: Food and Drug Administration, FDA, REUTERS, U.S . Food, Drug Administration, ByHeart Inc, Mead Johnson Nutrition, Abbott Laboratories, Thomson Locations: White Oak , Maryland, U.S, PRGO.N, Wisconsin, Michigan, Bengaluru
July 13 (Reuters) - The U.S. Food and Drug Administration on Thursday approved the first over-the-counter contraceptive pill, paving the way for millions of women in the country to purchase birth control without prescription. Perrigo will next week share its pricing plan for the pill, which will be available in stores and online in the first quarter of next year. Women should take a progestin-only pill within the same three hours every day to avoid pregnancy. The National Catholic Bioethics Center and other groups have opposed making Opill available without prescription, saying physicians should be involved in health decisions, especially for teenagers, along with parental supervision, to avoid harm. Perrigo gained the daily-use pill first through its $2.13 billion acquisition of Paris-based HRA Pharma in 2021.
Persons: Roe, Wade, Xavier Becerra, Opill, Jeffrey Singer, Perrigo, Manas Mishra, Sriparna Roy, Arun Koyyur Organizations: U.S . Food, Drug Administration, Perrigo, Human Services, Cato Institute, FDA, Catholic Bioethics Center, HRA Pharma, Thomson Locations: U.S, Paris, Bengaluru
U.S. FDA advisers back OTC use of Perrigo's birth control pill
  + stars: | 2023-05-10 | by ( ) www.reuters.com   time to read: +1 min
May 10 (Reuters) - A U.S. Food and Drug Administration advisory panel on Wednesday voted in favor of using Perrigo Co's (PRGO.N) contraceptive without a prescription, paving the way for the country's first approval for an over-the-counter birth control pill. The panel remained positive on the effectiveness of the pill, not only in the general population of women but also in adolescent populations and those with limited literacy. Perrigo's Opill, currently approved for prescription use, would be the first OTC non-estrogen contraceptive pill in the United States if approved by the regulator. The FDA generally follows the advise of its experts, though it is not bound to do so. Reporting by Sriparna Roy and Nandhini Srinivasan in Bengaluru; Editing by Shailesh KuberOur Standards: The Thomson Reuters Trust Principles.
[1/3] Mead Johnson's product Enfamil baby formula are displayed on a store shelf in New York City, U.S., February 10, 2017. Panicked parents had earlier this year emptied the baby formula aisles at supermarkets after former top U.S. manufacturer Abbott Laboratories (ABT.N) in February recalled dozens of types of its Similac, Alimentum and EleCare formulas. Since the Abbott recall, share of Reckitt in the infant formula market has skyrocketed, making it the No.1 supplier in the United States. Companies normally bid for state contracts to be the sole provider of baby formula for low-income families under the Women, Infants and Children (WIC) programme. Reckitt has said its formula factories are operating 24/7, and it was feeding more than 40% of all low-income WIC infants.
NEW YORK, Nov 1 (Reuters) - Infant formula manufacturer Perrigo Company Plc (PRGO.N) said on Tuesday it is buying the Good Start brand and a Wisconsin plant that makes the product from Nestle SA (NESN.S), as U.S. retailers recover from shortages of the good. The deal is part of a $170 million investment that Perrigo is making in its U.S. infant formula manufacturing. The investment includes $60 million to expand the plant's capacity by roughly 100 million eight-ounce bottles each year. Nestle has sent cans of specialized Alfamino formula and NAN from Europe to help try to alleviate the shortage earlier this year. Perrigo will supply Nestle with Good Start formula so the company can fulfill its contracts with the Women, Infants and Children program, which helps poor families afford the item.
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