USFDA Approval granted for Fluphenazine Hydrochloride Tablets

This recognition positions the medication as a generic alternative to Prolixin Tablets, initially developed by Apothecon.

The Health Master

November 13, 2023

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Table of Contents

Last Updated on December 22, 2024 by The Health Master

USFDA Approval

The pharmaceutical industry is abuzz with the recent news of Glenmark Pharmaceuticals receiving final USFDA approval from the United States Food & Drug Administration (USFDA) for Fluphenazine Hydrochloride Tablets USP in various strengths, including 1 mg, 2.5 mg, 5 mg, and 10 mg.

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This approval marks a significant milestone for Glenmark and the generic pharmaceutical sector as a whole.

Approval Details

1. USFDA Nod for Fluphenazine Hydrochloride Tablets USP

Glenmark’s Fluphenazine Hydrochloride Tablets have garnered the final stamp of approval from the USFDA.

This recognition positions the medication as a generic alternative to Prolixin Tablets, initially developed by Apothecon.

Understanding the specifics of this approval sheds light on the pathway for the drug’s availability in the market.

2. Distribution Plans by Glenmark Pharmaceuticals US

The responsibility of distributing these newly approved tablets in the US market falls on Glenmark Pharmaceuticals US.

Delving into the intricacies of the distribution process provides insights into the accessibility of this medication for consumers.

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Market Impact

1. Insights from IQVIA Sales Data

IQVIA sales data for the 12‐month period ending September 2023 reveals that Prolixin Tablets, in varying strengths, achieved annual sales of approximately $18.1 million.

Analyzing the impact of this data on the market and Glenmark Pharmaceuticals elucidates the competitive landscape.

2. Competitive Landscape and Market Growth

Glenmark’s entrance into the market with Fluphenazine Hydrochloride Tablets prompts an exploration of its competitive positioning.

Additionally, the potential growth in the market due to this USFDA approval is a factor worth considering.

Glenmark’s Portfolio

A. Current Product Lineup

Glenmark boasts a portfolio of 189 products authorized for distribution in the U.S. marketplace.

Understanding the diversity and scale of their current offerings provides context for the significance of the recent USFDA approval.

B. ANDAs Pending Approval

With 50 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA, Glenmark anticipates further expansions in its portfolio.

Assessing the potential contributions of these pending approvals adds another layer to the company’s growth strategy.

FAQs

Is Fluphenazine Hydrochloride Tablets the only USFDA-approved medication by Glenmark Pharmaceuticals?
- No, Glenmark has a diverse portfolio of 189 products authorized for distribution in the U.S. market.
What does IQVIA sales data reveal about Prolixin Tablets?
- IQVIA sales data for the 12-month period ending September 2023 indicates approximately $18.1 million in annual sales for Prolixin Tablets.
Who will be responsible for distributing Fluphenazine Hydrochloride Tablets in the US?
- Glenmark Pharmaceuticals US will handle the distribution of the newly approved tablets in the US market.
How many ANDAs are pending approval for Glenmark Pharmaceuticals?
- Currently, Glenmark has 50 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA.
What is the significance of the USFDA approval for Fluphenazine Hydrochloride Tablets?
- The USFDA approval positions Glenmark Pharmaceuticals as a key player in the generic pharmaceutical sector, offering an alternative to Prolixin Tablets in various strengths.