Last Updated on October 16, 2024 by The Health Master
USFDA approval
Alembic Pharmaceuticals, a leading global pharmaceutical company, has achieved a significant milestone with the US Food and Drug Administration’s (USFDA) final approval of its Abbreviated New Drug Application (ANDA) for Paliperidone Extended-Release Tablets.
This marks a crucial step in providing a generic alternative to the brand-name drug, Invega Extended-Release Tablets.
Addressing Schizophrenia and Schizoaffective Disorder
Paliperidone Extended-Release Tablets are a valuable medication used to treat schizophrenia and schizoaffective disorder.
These conditions can significantly impact a person’s life, and having access to effective and affordable treatment options is essential.
Alembic’s generic version aims to improve patient access and affordability while maintaining the same therapeutic benefits as the original brand-name drug.
Market Potential and Competitive Landscape
The market for Paliperidone Extended-Release Tablets is substantial, with an estimated value of US$ 48 million for the twelve months ending June 2024.
Alembic’s approval positions the company to capitalize on this market opportunity and compete effectively against other players in the generic drug space.
A Growing Portfolio of USFDA-Approved Products
This latest USFDA approval adds to Alembic’s impressive track record of securing regulatory approvals for its products.
With a total of 215 ANDA approvals, including 187 final approvals and 28 tentative approvals, Alembic has demonstrated its commitment to innovation and quality in the pharmaceutical industry.
In conclusion, Alembic Pharmaceuticals’ USFDA approval for Paliperidone Extended-Release Tablets is a positive development for patients seeking affordable treatment options for schizophrenia and schizoaffective disorder.
By providing a generic alternative, Alembic is contributing to improved access to mental health care and reinforcing its position as a trusted player in the pharmaceutical industry.
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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