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© 2022 MJH Life Sciences and Formulary Watch. All rights reserved.
© 2022 MJH Life Sciences™ and Formulary Watch. All rights reserved.
December 02, 2022
Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.
November 14, 2022
The approval extends the use of Liletta for an additional two years. It is the only hormonal IUD approved for continuous use up to eight years.
November 07, 2022
The greatest reductions were seen in girls who were vaccinated when they were adolescents, with up to 73% reduction in cervical pre-cancerous lesions.
October 27, 2022
If approved, Perrigo’s Opill could be the first-ever nonprescription birth control pill.
September 13, 2022
If approved, Perrigo’s Opill could be the first-ever over-the-counter birth control pill. The advisory committee meeting is scheduled for Nov. 18, 2022.
August 19, 2022
Mirena, a long-acting hormonal IUD, was previously approved to prevent pregnancy for up to seven years.
August 18, 2022
If approved, fezolinetant would treat patients with moderate-to-severe hot flashes and/or night sweats associated with menopause. The PDUFA date is Feb 22, 2023.
August 09, 2022
The approval had been delayed as the regulatory agency reviewed data on Myfembree's impact on bone mineral density.
May 09, 2022
Regulators need additional time to review information on bone mineral density. The FDA has provided a new PDUFA date of Aug. 6, 2022.
May 04, 2022
The FDA has made the labels consistent for combined hormonal contraceptives about the risk these products have to women who have or have had breast cancer.