Last Updated on December 21, 2024 by The Health Master
USFDA approval
USFDA Approval: Granules India, a leading pharmaceutical company, has announced a significant milestone in its journey of providing affordable healthcare solutions.
The company has received USFDA approval from the US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Trazodone Hydrochloride Tablets USP.
This green light paves the way for Granules India to introduce a generic version of the widely prescribed antidepressant, Desyrel.
A Breakthrough for Affordable Depression Treatment
Trazodone, the active ingredient in the approved tablets, is a medication commonly used to treat major depressive disorder in adults.
The UAFDA approval for Granules India’s ANDA means that the company can now manufacture and market a generic equivalent of Desyrel, offering patients a more affordable treatment option.
The generic Trazodone tablets will be available in strengths of 50 mg, 100 mg, 150 mg, and 300 mg.
These formulations have been rigorously tested and found to be bioequivalent and therapeutically equivalent to the original brand-name drug.
A Promising Market Opportunity
The US market for Trazodone tablets is substantial, with annual sales estimated at approximately $128 million, according to data from IQVIA/IMS Health.
Granules India’s entry into this market with its affordable generic version is expected to benefit a large patient population struggling with depression.
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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