Last Updated on August 19, 2024 by The Health Master
USFDA approval
Indian pharmaceutical giant, Alembic Pharmaceuticals, has announced a significant milestone in its US market expansion regarding the USFDA approval of the product.
The company has received final USFDA approval from the stringent US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) of Acitretin Capsules.
Available in strengths of 10 mg, 17.5 mg, and 25 mg, the drug is a generic equivalent to Stiefel Laboratories’ Soriatane Capsules.
A Promising Drug for Severe Psoriasis
Acitretin is a retinoid medication prescribed for the treatment of severe psoriasis in adults.
This chronic autoimmune disease causes itchy, scaly patches on the skin.
With Alembic’s latest USFDA approval, patients in the US can now access a more affordable treatment option for this debilitating condition.
Substantial Market Potential
The market for Acitretin Capsules is substantial, with an estimated value of $21 million for the twelve months ending June 2024, according to industry data provider IQVIA.
This USFDA approval is expected to bolster Alembic’s financial performance and solidify its position in the US generic drug market.
Alembic’s Strong US Footprint
This latest USFDA approval marks another feather in Alembic’s cap.
The company has now secured a cumulative total of 212 ANDA approvals, including 184 final USFDA approvals and 28 tentative USFDA approvals.
This impressive track record underscores Alembic’s commitment to providing high-quality, affordable generic medications to patients in the United States.
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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