The U.S. Food and Drug Administration issued warning letters to three infant formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, reflecting findings from FDA inspections of these facilities over the last several months.
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The daily contraceptive Opill, sold by Perrigo, was first approved for prescription use in 1973, and the over-the-counter approval clears the way for people to obtain it without first seeing a healthcare provider.
The joint committee of external experts voted unanimously in favor of Perrigo, finding that the benefits of allowing non-prescription use of the birth control tablet Opill outweigh its risks.
The U.S. health regulator’s reviewers on Friday raised concerns around allowing Perrigo Co’s birth control drug over the counter, saying switching to non-prescription sale could lead to inappropriate usage by consumers.
The panel will decide on recommending the non-estrogen contraceptive as a daily OTC birth control pill on May 9 and 10. The drug, Opill, is expected to be the first such pill in the United States if approved.
Perrigo Co. Plc said on Monday that the U.S. Food and Drug Administration had scheduled a meeting of external experts on Nov. 18 to review the application of its daily birth control pill for over-the-counter (OTC) use.
Perrigo Company said on Monday its HRA Pharma unit has asked the U.S. Food and Drug Administration (FDA) to approve a daily birth control pill for over-the-counter (OTC) sale, the first such request for this type of contraception. HRA Pharma expects the regulator to hold an advisory committee meeting and approve the application in the first half of 2023, which is typical for such requests, said Frédérique Welgryn, HRA Pharma’s chief strategic operations and innovation officer.