Last Updated on August 21, 2024 by The Health Master
USFDA approval
Hyderabad, India – Granules India, a leading pharmaceutical company, has announced a significant milestone with the US Food and Drug Administration approval (USFDA approval) of its Abbreviated New Drug Application (ANDA) for Glycopyrrolate Oral Solution 1mg/5mL.
This groundbreaking development marks a crucial step forward in the treatment of drooling in pediatric patients.
Addressing a Significant Unmet Need
Glycopyrrolate Oral Solution is a vital medication prescribed to children aged 3 to 16 years who grapple with excessive drooling due to neurological conditions.
The USFDA approval of Granules India’s generic version brings much-needed relief and improved treatment options to these young patients.
Generic Equivalent to Cuvposa Oral Solution
Granules Pharmaceuticals, a wholly-owned subsidiary of Granules India, successfully filed the ANDA for Glycopyrrolate Oral Solution.
The approved generic is bioequivalent and therapeutically equivalent to the brand-name drug, Cuvposa Oral Solution, manufactured by Merz Pharmaceuticals.
This equivalence ensures that patients can access an affordable and effective treatment alternative.
Expanding Granules India’s US Market Presence
The USFDA approval of Glycopyrrolate Oral Solution underscores Granules India’s commitment to providing high-quality, affordable generic medications to patients in the United States.
This achievement further solidifies the company’s position as a key player in the US pharmaceutical market.
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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