USFDA tentative approval granted for Apalutamide tablets

After receiving USFDA tentative approval, rigorous post-market surveillance ensures the ongoing safety and effectiveness of the drug.

The Health Master

October 14, 2023

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Last Updated on December 22, 2024 by The Health Master

USFDA tentative approval

Lupin, a prominent pharmaceutical player, has achieved a significant milestone in the realm of USFDA tentative approval for Apalutamide tablets.

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The United States Food and Drug Administration (USFDA) has granted tentative approval for Lupin’s Abbreviated New Drug Application (ANDA) for Apalutamide Tablets, 60 mg.

This marks a major stride towards introducing a generic equivalent of Janssen Biotech’s Erleada Tablets, 60 mg, to the market.

Manufacturing Hub in Pithampur

The approved product will be manufactured at Lupin’s state-of-the-art facility in Pithampur, India.

This facility, known for its adherence to stringent quality standards, is poised to play a pivotal role in bringing this crucial drug to patients in need.

Understanding Apalutamide Tablets

Apalutamide Tablets, 60 mg, also known as the Reference Listed Drug (RLD) Erleada, are a vital pharmaceutical offering in the fight against specific health conditions.

With estimated annual sales of $1,185.5 million in the US (according to IQVIA MAT July 2023 data), this drug holds significant promise in terms of both medical efficacy and market impact.

Post-Market Surveillance and Labeling Requirements

After receiving USFDA tentative approval, rigorous post-market surveillance ensures the ongoing safety and effectiveness of the drug.

Compliance with USFDA Drug Labeling Requirements is imperative to provide accurate information to healthcare professionals and patients.

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Key Steps in FDA Drug Approval Process

To fully appreciate this achievement, it is imperative to understand the intricate process that leads to an USFDA approval.

Below are the key steps involved:

Regulatory Affairs Consulting: Engaging experts in regulatory affairs can provide invaluable guidance in navigating the complex landscape of drug approvals.
USFDA Drug Approval Pathway: Lupin followed the Generic Drug Approval Pathway, seeking to produce a cost-effective equivalent of a previously approved brand-name drug.
Fast Track Designation and Breakthrough Therapy Designation: These USFDA designations can expedite the approval process for drugs that address critical unmet medical needs.
Biologics License Application (BLA) Process: While not applicable in this case, this process is crucial for the approval of biological products.
Orphan Drug Designation Process: For drugs aimed at treating rare diseases, obtaining orphan drug designation can provide incentives and streamlined approval pathways.
Priority Review Process: This designation is granted to drugs that offer significant advancements in treatment, expediting their evaluation.
Accelerated Approval Process USFDA: This pathway allows for earlier approval of drugs that treat serious conditions, based on surrogate endpoints.
Expedited Programs and Review: Various programs are available to speed up the review process, including Accelerated Approval, Fast Track, Breakthrough Therapy, and Priority Review.
Advisory Committee Review: Expert committees provide independent recommendations on drug approvals.
USFDA Centre for Drug Evaluation and Research (CDER) and Office of New Drugs (OND): These are pivotal bodies responsible for evaluating drugs and overseeing their approval.

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.