MedPath

Mayne Pharma Commercial LLC

🇺🇸United States
Ownership
-
Employees
-
Market Cap
-
Website

Clinical Trials

2

Active:2
Completed:0

Trial Phases

1 Phases

Phase 1:2

Drug Approvals

45

FDA:45

Drug Approvals

calcipotriene

Approval Date
Mar 13, 2024
FDA

tavaborole

Approval Date
Mar 5, 2024
FDA

Tazarotene

Approval Date
Mar 5, 2024
FDA

Amiodarone Hydrochloride

Approval Date
Mar 1, 2024
FDA

Tolsura

Approval Date
Mar 1, 2024
FDA

Clozapine

Approval Date
Feb 28, 2024
FDA

Fentanyl Buccal

Approval Date
Feb 15, 2024
FDA

Dapsone

Approval Date
Jan 31, 2024
FDA

butalbital and acetaminophen

Approval Date
Jan 9, 2024
FDA

butalbital, acetaminophen and caffeine

Approval Date
Jan 9, 2024
FDA
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Clinical Trials

Distribution across different clinical trial phases (2 trials with phase data)• Click on a phase to view related trials

Phase 1
2 (100.0%)
No trials found

News

FDA Expert Panel Calls for Revision of Menopausal Hormone Therapy Warning Labels

An FDA expert panel convened to reassess boxed warnings for menopausal hormone therapy, with multiple experts arguing that current labels overstate risks and are not supported by comprehensive scientific evidence.

FDA Issues Warning to Mayne Pharma for Misleading Nextstellis Birth Control Safety Claims

The FDA's Office of Prescription Drug Promotion has cited Mayne Pharma for making misleading safety claims about its oral contraceptive Nextstellis in promotional materials.

Sol-Gel and Mayne Pharma Announce $16 Million Deal for EPSOLAY and TWYNEO Rights in the U.S.

• Sol-Gel Technologies has entered into a $16 million agreement with Mayne Pharma for the sale and exclusive license of U.S. rights to dermatology products EPSOLAY and TWYNEO, extending the company's cash runway into Q1 2027. • The transaction allows Sol-Gel to focus resources on its promising SGT-610 program for Gorlin syndrome, which has completed 80% patient recruitment for Phase III trials with top-line results expected in Q4 2026. • Based on recent market research, Sol-Gel estimates SGT-610's U.S. market potential between $400-500 million annually as the first potential preventative treatment for basal cell carcinomas in Gorlin syndrome patients.

North Carolina Emerges as Global Bioscience Hub with $2.5B International Investment Surge

North Carolina has attracted 71 international life science companies from 20 countries, generating over $2.5 billion in investments and creating 17,000 jobs in the past five years.

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