Last Updated on December 21, 2024 by The Health Master
USFDA approval
Zydus Lifesciences, a leading global pharmaceutical company, has achieved a significant milestone with the final USFDA approval from the United States Food and Drug Administration (USFDA) to market its generic version of Valbenazine Capsules.
Available in strengths of 40 mg, 60 mg, and 80 mg, the drug is a replica of the brand-name Ingrezza Capsules.
Targeting Tardive Dyskinesia
Valbenazine Capsules are specifically designed to treat tardive dyskinesia, a debilitating condition characterized by involuntary and repetitive movements of the face, tongue, and other body parts.
This USFDA approval marks a crucial step forward in providing accessible and affordable treatment options for patients suffering from this often distressing disorder.
Pioneering Generic Development
Zydus Lifesciences has demonstrated its commitment to patient care by being among the first to submit a substantially complete Abbreviated New Drug Application (ANDA) with a Paragraph IV certification for Valbenazine Capsules in both the 40 mg and 80 mg strengths.
Moreover, the company holds the distinction of being the initial ANDA filer for the 60 mg dosage form.
Exclusive Market Rights
As a result of its pioneering efforts, Zydus Lifesciences is entitled to a 180-day period of shared generic drug exclusivity for Valbenazine Capsules in the 40 mg and 80 mg strengths.
Additionally, the company will enjoy a sole 180-day exclusivity period for the 60 mg dosage form.
This exclusivity period provides Zydus with a competitive advantage in the market and allows for greater investment in research and development.
Substantial Market Opportunity
The USFDA approval of Valbenazine Capsules is a strategic move for Zydus Lifesciences, considering the substantial market potential of the drug.
With annual sales of $1.99 billion in the United States alone, Valbenazine represents a significant commercial opportunity for the company.
Manufacturing Excellence
Zydus Lifesciences will manufacture Valbenazine Capsules at its state-of-the-art formulation manufacturing facility located in Ahmedabad SEZ – II, India.
This facility adheres to stringent quality standards and regulatory requirements, ensuring the consistent production of high-quality medicines.
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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