Mayne Pharma
55 articles about Mayne Pharma
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Mayne Pharma to Present at the 42nd Annual J.P. Morgan Healthcare Conference
12/29/2023
Mayne Pharma Group Limited announced that Shawn Patrick O’Brien, Chief Executive Officer of Mayne Pharma, will present at the 42nd Annual J.P. Morgan Healthcare Conference as follows.
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Dr. Reddy's Laboratories Announces Agreement to Acquire Mayne Pharma’s U.S. Generic Prescription Product Portfolio
2/27/2023
Dr. Reddy's Laboratories SA today announced that it has entered into a definitive agreement to acquire the U.S. generic prescription product portfolio of Salisbury, Australia, based Mayne Pharma Group Limited (ASX: MYX).
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TherapeuticsMD Completes Transaction to License Its Products to Mayne Pharma
1/3/2023
TherapeuticsMD, Inc. (NASDAQ: TXMD) (“TherapeuticsMD,” “TXMD” or the “Company”), an innovative, leading women’s healthcare company, today announced that it has completed its previously announced transaction with Mayne Pharma Group Limited.
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TherapeuticsMD Announces Definitive Agreements to License its Products to Mayne Pharma
12/4/2022
TherapeuticsMD, Inc. announced that it has entered into definitive agreements to license its products to an affiliate of Mayne Pharma Group Limited, an ASX-listed specialty pharmaceutical company focused on commercializing novel and generic pharmaceuticals, for commercialization in the United States.
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NEXTSTELLIS® oral contraceptive has been nominated for the 2022 prix galien usa award for best pharmaceutical agent
8/2/2022
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.
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FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
9/21/2021
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.
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The filing accused Mayne Pharma, which also has operations in the U.S., of breaching disclosure obligations with regard to anti-competitive conduct.
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New Efficacy Data Reinforces NEXTSTELLIS® Benefits Across Patient Populations
4/30/2021
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 [1] and prior contraceptive use.
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U.S. FDA Approves NEXTSTELLIS®, New Oral Contraceptive
4/16/2021
First approved product containing estetrol (E4), the first new estrogen introduced in the U.S. in over 50 years
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Clinical Catch-Up: March 8-12
3/15/2021
It 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
3/6/2021
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.
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New Data On Mayne Pharma's Tolsura® (SUBA®-itraconazole) Presented At IDWeek 2020
10/26/2020
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.
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Mayne Pharma Launches Chlorzoxazone Tablet in the United States
7/27/2020
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.
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Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
6/24/2020
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.
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Mayne Pharma launches BAC 300 capsules in the United States
5/22/2020
Mayne Pharma Group Limited is pleased to announce the launch of butalbital acetaminophen and caffeine capsule 50mg/300mg/40mg in the United States.
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Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA
4/16/2020
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.
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Mayne Pharma Signs 20-Year Exclusive License and Supply Agreement for Novel Oral Contraceptive in the US
10/2/2019
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.
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FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
5/22/2019
Mayne Pharma Group Limited is pleased to announce that the US Food and Drug Administration has approved SORILUX® Foam, 0.005% in adolescents.
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Sorilux was approved for the treatment of patients age 12 and up.