Lupin Stock Surges on USFDA Granting Tentative Approval for Key Enzalutamide Tablets
Lupin shares saw a positive uptick following the announcement that the drugmaker received tentative approval from the U.S. Food and Drug Administration (USFDA). The approval pertains to its Abbreviated New Drug Application (ANDA) for Enzalutamide Tablets in various strengths, including 40 mg, 80 mg, 120 mg, and 160 mg.The stock reflected the positive sentiment, trading at Rs 2,360.60, which was up by Rs 18.45 or 0.79 percent. The company touched an intraday high of Rs 2,371.05 and maintained an intraday low of Rs 2,344.90 on the BSE.
Scope of Enzalutamide Tablet Approval by USFDA
The USFDA has tentatively approved the 40 mg and 80 mg strengths of Lupin’s Enzalutamide Tablets as being bioequivalent to Xtandi Tablets manufactured by Astellas. This pivotal approval secures a significant market opportunity for the drugmaker.Crucially, while competitors typically offer tablets in the 40 mg and 80 mg dosages, Lupin has secured tentative approval for its higher strengths: 120 mg and 160 mg. These additional dosing options will provide valuable alternatives to healthcare providers and patients across various treatment settings.
Recent USFDA Milestones and Product Launches
The pharmaceutical firm has continued to expand its product portfolio, securing several key approvals in recent months. Earlier this month, Lupin launched Azilsartan Medoxomil Tablets, available in 40 mg and 80 mg strengths, following receipt of approval from the USFDA.In a further testament to its growing regulatory successes, the company also received USFDA approval for ranibizumab, marketed as RanluspecTM (ranibizumab-hkdz).
International Partnerships Drive Growth Strategy
Lupin has successfully secured significant international collaborations aimed at expanding market reach for various products. The company partnered with Natco Pharma and the USFDA granted approval for Eribulin Mesylate Injection in a single dose vial, priced at 1 mg/2 mL (0.5 mg/mL).A notable strategic collaboration involves the Spanish pharmaceutical firm LABORATORIOS ERN S.A. (ERN). This partnership is focused on launching Luforbec (beclometasone/formoterol) 100/6 in Spain. The drug, a fixed dose combination, will be offered in a pressurized metered dose inhaler for treating chronic obstructive pulmonary disease and adult asthma.
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