Zydus Lifesciences Receives USFDA Approval for Tardive Dyskinesia Treatment
Final Approval Granted for Ingrezza Capsules
Mumbai, India – December 16, 2022
Zydus Lifesciences Limited, a global pharmaceutical company, has announced that it has received final approval from the United States Food and Drug Administration (USFDA) to market Ingrezza (valbenazine) capsules for the treatment of adults with tardive dyskinesia, a movement disorder caused by long-term use of antipsychotic medications.
Ingrezza, an oral medication, has been approved by the USFDA based on positive results from two Phase III clinical trials that demonstrated significant reduction in involuntary movements in patients with tardive dyskinesia.
"This approval is a significant milestone for Zydus Lifesciences and our commitment to developing innovative treatments for patients with neurological disorders," said Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Limited. "Ingrezza provides a much-needed therapeutic option for patients who have been struggling with tardive dyskinesia and its debilitating symptoms."
Tardive dyskinesia affects approximately 500,000 people in the United States and is characterized by involuntary, repetitive movements of the face, mouth, and limbs.
The approval of Ingrezza marks a significant step forward in the treatment of tardive dyskinesia and underscores the company's dedication to improving the lives of patients with neurological conditions.
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