Pharma Stock Receives US FDA Tentative Approval for Enzalutamide Tablets in Four Strengths
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Lupin Limited has received tentative approval from the US FDA for its Enzalutamide Tablets in 40 mg, 80 mg, 120 mg and 160 mg strengths, including two additional dosing options not currently available in the reference listed drug.
✨ Key Takeaways
Gift Nifty fell over 150 points on Friday morning, signalling weak global cues. However, Indian equity markets remain closed today on account of Muharram.
On Thursday, Indian benchmark indices ended marginally higher, with the Nifty 50 gaining 34.35 points, or 0.14 per cent, to close at 24,056.00. Despite the positive market sentiment, Lupin Limited share prices ended 1.02 per cent lower at Rs 2,343.50.
US FDA Grants Tentative Approval
Lupin Limited has received tentative approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in 40 mg, 80 mg, 120 mg and 160 mg strengths.
The US FDA confirmed that Lupin's 40 mg and 80 mg tablets are bioequivalent to Xtandi Tablets, the reference listed drug marketed by Astellas, for the approved indications.
Additional Dosing Options
In addition to the standard 40 mg and 80 mg strengths available for the reference product, Lupin has also received tentative approval for 120 mg and 160 mg strengths. These additional dosage strengths are expected to provide healthcare professionals and patients with greater dosing flexibility that is not currently available with the reference listed drug.
A tentative approval signifies that the application meets the US FDA's quality, safety and efficacy requirements. However, the product cannot be commercially launched until applicable patent protections or exclusivity periods expire and final approval is granted.
Expands US Generic Portfolio
The latest approval further strengthens Lupin's portfolio in the highly competitive US generics market. The company continues to focus on expanding its presence through complex generic products, differentiated dosage forms and specialty pharmaceuticals, reinforcing its long-term growth strategy in regulated markets.
About the Company
Lupin Limited is one of India's leading pharmaceutical companies with operations across more than 100 countries. The company develops and manufactures branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs), serving therapeutic segments including respiratory, cardiovascular, diabetes, gastroenterology, anti-infectives, central nervous system and women's health.
The company operates 15 manufacturing facilities and seven research centres globally, supported by a workforce of over 24,000 employees. Through continuous investments in research, innovation and regulatory approvals, Lupin continues to strengthen its position as one of India's leading global pharmaceutical companies.
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Disclaimer: The article is for informational purposes only and not investment advice.