Last Updated on July 24, 2024 by The Health Master
USFDA approval
Indian pharmaceutical giant, Alembic Pharmaceuticals, has announced a significant milestone in its US market expansion. The company has received final USFDA approval from the stringent US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Fluphenazine Hydrochloride Tablets.
This green light paves the way for Alembic to introduce generic versions of Prolixin Tablets in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg into the US market.
Fluphenazine Hydrochloride: A Key Treatment Option
Fluphenazine hydrochloride is a widely prescribed medication used in managing the symptoms of psychotic disorders.
Its therapeutic equivalence to the reference listed drug, Prolixin, manufactured by Apothecon, has been established through rigorous evaluation by the USFDA.
Alembic’s Strong US Footprint
This latest USFDA approval solidifies Alembic’s position as a leading player in the US generic pharmaceutical market.
With a cumulative tally of 210 ANDA approvals, including 182 final USFDA approvals and 28 tentative USFDA approvals, the company has demonstrated a consistent track record of success in gaining regulatory clearances.
Key Takeaways:
- Alembic Pharmaceuticals has received USFDA approval for generic Fluphenazine Hydrochloride Tablets.
- The drug will be available in strengths of 1 mg, 2.5 mg, 5 mg, and 10 mg.
- Fluphenazine hydrochloride is indicated for managing psychotic disorders.
- Alembic now has a total of 210 ANDA approvals from the USFDA.
This latest achievement underscores Alembic’s commitment to providing high-quality, affordable generic medications to patients in the United States.
As the company continues to expand its product portfolio, it is poised to make a substantial impact on healthcare accessibility and affordability.
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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