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51 articles with Mayne Pharma
NEXTSTELLIS® oral contraceptive has been nominated for the 2022 prix galien usa award for best pharmaceutical agent
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA are pleased to announce NEXTSTELLIS® has been nominated for the 2022 Prix Galien USA Award for Best Pharmaceutical Agent.
Mayne Pharma is pleased to announce that the U.S. Food and Drug Administration (FDA) has approved LEXETTE® (halobetasol propionate) foam, 0.05% for use in adolescents. LEXETTE, a super potent topical corticosteroid, is now approved for the treatment of plaque psoriasis in patients aged 12 years and older.
The filing accused Mayne Pharma, which also has operations in the U.S., of breaching disclosure obligations with regard to anti-competitive conduct.
5/10/2021It was a busy week for clinical trial news. Here’s a look.
Mayne Pharma announced results from two studies showing treatment with NEXTSTELLIS® demonstrated contraceptive efficacy and excellent cycle control across subgroups, including age, body mass index  and prior contraceptive use.
First approved product containing estetrol (E4), the first new estrogen introduced in the U.S. in over 50 years
3/15/2021It was another busy week for clinical trial announcements. Here’s a look including trials for COVID-19, migraine, Parkinson's disease, Alzheimer's, HIV and more.
New Data Show NEXTSTELLIS® Has Selective Impact On Endocrine Markers Compared With Common Combined Oral Contraceptives
Mayne Pharma announced new data showing treatment with NEXTSTELLIS®,1 a novel, investigational combined oral contraceptive containing drospirenone and estetrol, resulted in limited changes in endocrine markers, including lower increases in hormone binding globulins, compared with COCs based on ethinyl-estradiol, the synthetic estrogen used in all but one of the marketed COCs.
Mayne Pharma Group Limited is pleased to announce that new clinical data has been presented on TOLSURA® at IDWeek 2020, being held virtually in the US from October 21st-25th.
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has granted approval of its Abbreviated New Drug Application (ANDA) for chlorzoxazone tablet, 375 mg, 500 mg and 750 mg, in the United States . Mayne Pharma has commenced commercial launch activities to customers in the US.
Mayne Pharma Group Limited is pleased to announce the New Drug Application for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration.
Mayne Pharma Group Limited is pleased to announce the launch of butalbital acetaminophen and caffeine capsule 50mg/300mg/40mg in the United States.
Mayne Pharma Group Limited and Mithra Pharmaceuticals, SA announced that Mayne Pharma has submitted a New Drug Application to the US Food and Drug Administration, seeking marketing authorisation for E4/DRSP, a combined oral contraceptive indicated for the prevention of pregnancy.
Mayne Pharma Signs 20-Year Exclusive License and Supply Agreement for Novel Oral Contraceptive in the US
Mayne Pharma is pleased to announce it has entered into an exclusive license and supply agreement with Mithra to commercialise E4/DRSP, a combined oral contraceptive, in the United States.
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration has approved SORILUX® Foam, 0.005% in adolescents.
Sorilux was approved for the treatment of patients age 12 and up.
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration has approved the trade name LEXETTE™ for the approved drug halobetasol propionate foam, 0.05%.
Anchored by Raleigh, Durham and the Research Triangle Park region, BioSpace’s Bio NC Hotbed is one of the faster-growing areas for biopharma in the U.S.
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of LEXETTE™ (halobetasol propionate) Foam 0.05% in the United States.
Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of TOLSURA™ (SUBA®-itraconazole) 65mg capsule in the United States.