Last Updated on December 13, 2024 by The Health Master
USFDA
Gland Pharma, a prominent player in the generic injectables market, has secured crucial approval from the stringent US Food and Drug Administration (USFDA) for its Latanoprost Ophthalmic Solution, a 0.005% formulation.
This regulatory milestone signifies a significant step forward for the company, opening doors to a lucrative market opportunity.
Key Highlights
- Therapeutic Equivalence: The USFDA approved product is bioequivalent and therapeutically equivalent to the brand-name drug Xalatan, manufactured by Upjohn US 2 LLC.
- Therapeutic Indication: Latanoprost Ophthalmic Solution is indicated for the treatment of elevated intraocular pressure in patients diagnosed with open-angle glaucoma or ocular hypertension.
- Market Launch: Gland Pharma aims to introduce the product in the United States market during the fiscal year 2025, leveraging its established distribution network and marketing partnerships.
- Market Potential: According to IQVIA data, the US market for Latanoprost Ophthalmic Solution was valued at approximately USD 111.6 million in the twelve months ending December 2023.
Disclaimer: This article contains information derived from the source mentioned below. Our team utilized an AI language model to rewrite and present the news or article in a unique format.
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