Lupin gets tentative US FDA nod for apalutamide tablets

Lupin gets tentative US FDA nod for apalutamide tablets

Mumbai-based pharmaceutical powerhouse, Lupin Limited, unveiled a significant milestone on Friday as it obtained provisional approval from the United States Food and Drug Administration (US FDA). The nod from the US FDA greenlights Lupin’s abbreviated new drug application for apalutamide tablets, 60 mg, thus paving the way for the production and marketing of a generic counterpart to Janssen Biotech, Inc.’s erleada tablets, 60 mg.

The manufacturing hub for this groundbreaking product will be Lupin’s state-of-the-art facility in Pithampur, India, reaffirming the company’s commitment to cutting-edge pharmaceutical innovation.

Apalutamide tablets, 60 mg (also recognized as RLD Erleada), have enjoyed impressive success in the US, with estimated annual sales of $1,185.5 million.

But Lupin’s list of achievements doesn’t stop there; the company has also clinched tentative US FDA approval for its abbreviated new drug application concerning calcium, magnesium, potassium, and sodium oxybates oral solution, 0.5 g/mL.

This significant nod from the US FDA gives Lupin the green light to introduce a generic counterpart to Jazz Pharmaceuticals Ireland Limited’s xywav oral solution, 0.5 g/mL. Lupin’s production facility in Somerset, US, will be responsible for bringing this innovative product to the market. Worth noting is that Lupin’s exclusive first-to-file status may make them eligible for a 180-day exclusivity period upon the product’s launch.

In the fiscal year ending December 2022, net product sales for calcium, magnesium, potassium, and sodium oxybates oral solution totaled a noteworthy USD 958.4 million, with an impressive USD 604.3 million generated during the initial six months of 2023.

As a testament to Lupin’s unwavering commitment to quality, the company also proudly revealed that it has received an Establishment Inspection Report (EIR) from the US FDA for its Nagpur Unit-I manufacturing facility. The EIR is the result of a thorough inspection conducted in July 2023. This achievement underscores Lupin’s dedication to maintaining the highest standards in pharmaceutical manufacturing and quality assurance.

About Lupin:

Lupin Limited, headquartered in Mumbai, is an Indian multinational pharmaceutical company with a strong global presence and a significant revenue share in the generic pharmaceutical industry. The company’s primary therapeutic areas of interest comprise paediatrics, cardiovascular diseases, anti-infectives, diabetology, asthma, and anti-tuberculosis drugs.

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