NEXTSTELLIS® oral contraceptive has been nominated for the 2022 prix galien usa award for best pharmaceutical agent
ADELAIDE, Australia, Aug. 2, 2022 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are pleased to announce NEXTSTELLIS® (drospirenone and estetrol tablets) has been nominated for the 2022 Prix GalienUSA Award for Best Pharmaceutical A...
MAYNE PHARMA AND GOODRX ANNOUNCE NEW INITIATIVE TO INCREASE AWARENESS OF NEXTSTELLIS® AND EXPAND ACCESS TO BIRTH CONTROL
* Mayne Pharma enters into strategic agreement with GoodRx * GoodRx and Mayne Pharma to collaborate and deliver an enhanced NEXTSTELLIS® direct-to-consumer (DTC) program ADELAIDE, Australia, July 29, 2022 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce a new strat...
Mayne Pharma and Mithra Announce TGA Approval of NEXTSTELLIS® Oral Contraceptive
ADELAIDE, Australia, Nov. 30, 2021 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) are very pleased to announce the Therapeutic Goods Administration (TGA) has approved the novel combined oral contraceptive NEXTSTELLIS® (14.2 mg of es...
FDA Approves LEXETTE (R) for Adolescent Plaque Psoriasis
RALEIGH, N.C., Sept. 21, 2021 /PRNewswire/ -- 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 ...
Mayne Pharma launches another generic oral contraceptive
ADELAIDE, Australia, March 4, 2021 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the commercial launch of a generic version of ORTHO-CEPT® (desogestrel and ethinyl estradiol 0.15 mg / 0.03 mg) tablets to customers in the US. This is the fourth oral contraceptive la...
New Data On Mayne Pharma's Tolsura® (SUBA®-itraconazole) Presented At IDWeek 2020
ADELAIDE, Australia, Oct. 26, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that new clinical data has been presented on TOLSURA® (SUBA®-itraconazole) at IDWeek 2020, being held virtually in the US fromOctober 21st-25th. The conference is attended by over 11,50...
Mayne Pharma Launches Chlorzoxazone Tablet in the United States
ADELAIDE, Australia, July 27, 2020 /PRNewswire/ -- 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, inthe United Stat...
Mayne Pharma Announces FDA Filing Acceptance of New Drug Application for E4/DRSP in the US
ADELAIDE, Australia, June 24, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the New Drug Application (NDA) for E4/DRSP to prevent pregnancy has been accepted for review by the US Food and Drug Administration (FDA). The FDA is expected to complete its review in ...
Mayne Pharma Executes 20 Year License and Supply Agreement for Novel Oral Contraceptive in Australia
ADELAIDE, Australia, May 28, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce it has entered into an exclusive long-term license and supply agreement with Mithra Pharmaceuticals SA (Mithra) to commercialise E4/DRSP, a combined oral contraceptive, inAustralia. E4...
Mayne Pharma launches BAC 300 capsules in the United States
ADELAIDE, Australia, May 22, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of butalbital acetaminophen and caffeine (BAC) capsule 50mg/300mg/40mg inthe United States. Mayne Pharma received approval from the US Food and Drug Administration for its Abb...
Mayne Pharma Submits New Drug Application for E4/DRSP to the FDA
ADELAIDE, Australia and LIEGE, Belgium, April 16, 2020 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) and Mithra Pharmaceuticals, SA (Euronext Brussels: MITRA) today announced that Mayne Pharma has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA), seeking...
Mayne Pharma Signs 20-Year Exclusive License and Supply Agreement for Novel Oral Contraceptive in the US
ADELAIDE, Australia, Oct. 2, 2019 * Mayne Pharma Group Limited (Mayne Pharma or Company) (ASX: MYX) has signed a 20‑year exclusive supply and license agreement with Mithra Pharmaceuticals, SA (Mithra) to commercialise a novel oral contraceptive comprising Estetrol (E4), and drospirenone, (E4/...
FDA Approves SORILUX(R) for Adolescent Plaque Psoriasis
ADELAIDE, Australia, May 22, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved SORILUX® (calcipotriene) Foam, 0.005% in adolescents. SORILUX is now approved for treating plaque psoriasis of the scalp and b...
FDA approves trade name Lexette(TM) (halobetasol propionate) foam, 0.05%
ADELAIDE, Australia, April 30, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved the trade name LEXETTE™ for the approved drug halobetasol propionate foam, 0.05%. LEXETTE is a new formulation of halobetas...
Mayne Pharma launches Lexette (TM) (halobetasol propionate) foam 0.05% in the United States
ADELAIDE, Australia, Feb. 13, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of LEXETTE™ (halobetasol propionate) Foam 0.05% inthe United States. LEXETTE, the conditionally-acceptable trade name for halobetasol foam is a new formulation of halobetas...
TOLSURA (TM) (SUBA®-itraconazole) Antifungal Capsule Now Available in the United States
ADELAIDE, Australia, Jan. 30, 2019 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce the launch of TOLSURA™ (SUBA®-itraconazole) 65mg capsule inthe United States. TOLSURA is a new formulation of itraconazole indicated for the treatment of systemic fungal infections incl...
Mayne Pharma receives FDA approval of Tolsura™ (SUBA®-itraconazole capsules) for the treatment of certain fungal infections
ADELAIDE, Australia, Dec. 11, 2018 /PRNewswire/ -- Mayne Pharma Group Limited (ASX: MYX) is pleased to announce that the US Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Tolsura™ (SUBA®-itraconazole) 65mg capsules. Tolsura is a new formulation of itraconazole...
Metrics Contract Services Announces Serialization Capabilities at Greenville Site
GREENVILLE, N.C., Nov. 12, 2018 /PRNewswire/ -- Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, is pleased to announce successful qualification of two commercial bottling lines for serialization at its newUS$80 million oral solid dose commercial manufacturing site...
Metrics Contract Services Adds Commercial Gerteis Roller Compaction Capabilities
GREENVILLE, N.C., Nov. 1, 2018 /PRNewswire/ -- Metrics Contract Services (Metrics), a division of Mayne Pharma Group Limited, has added a Gerteis Mini-Pactor® roller compactor to its granulation capabilities at its new US$80 million oral solid dose commercial manufacturing facility inGreenville, ...
Mayne Pharma Acquires FDA-approved halobetasol foam, Complementing US Dermatology Portfolio
ADELAIDE, Australia, Oct. 26, 2018 /PRNewswire/ -- * Mayne Pharma Group Limited ("Mayne Pharma") (ASX: MYX) has acquired the FDA approved halobetasol propionate foam 0.05% for an investment of up to US$32 million and an ongoing earn out payment * Halobetasol foam is a highly complementary d...
