Zydus Lifesciences Limited, on Tuesday, announced that it has received the final approval from the US Food and Drug Administration (FDA) to manufacture and market Estradiol Transdermal System.
Enforcement Report - Week of March 22, 2023
FDA Confirms Paragraph IV Patent Litigation for Elagolix Sodium, Estradiol, Norethindrone Acetate Capsules
Zydus' Generic Estradiol Receives Approval in the U.S.
Chemo's Generic Estradiol Receives Approval in the U.S.
After a bump in the road back in April, Myovant and Pfizer have won a label expansion covering Myfembree's use in endometriosis.
Earlier this year, the FDA sent letters to Pfizer and Myovant flagging problems that meant conversations about labeling or postmarketing requirements couldn't proceed for Myfembree in endometriosis pain. Since then, Myovant said in its quarterly earnings press release, the FDA provided it with labeling comments for the gonadotropin-releasing hormone (GnRH) antagonist.
Fagron Group B.V. Receives FDA Warning Letter
Around 4,500 people in the UK will be eligible for a new oral treatment for uterine fibroids. It follows the National Institute for Health and Care Excellence (NICE) recommendation of relugolix with estradiol and norethisterone acetate, also known as Ryeqo.
Enforcement Report - Week of February 9, 2022