Lupin Ltd Receives US FDA Approval for Travoprost Ophthalmic Solution

On May 6, 2024, Lupin Ltd informed the stock exchanges that the company got approval from the United States Food and Drug Administration (U.S. FDA) for its Abbreviated New Drug Application (ANDA) for Travoprost Ophthalmic Solution USP, 0.004%.

Travoprost Ophthalmic Solution USP, 0.004%, is an Ionic Buffered Solution. Lupin Ltd got approval from the United States FDA to market a generic equivalent to the reference listed drug (RLD) Travatan Z® Ophthalmic Solution, 0.004%, of Sandoz Inc. The product will be manufactured at Lupin Ltd’s Pithampur facility in India.

The company stated that Travoprost Ophthalmic Solution USP, 0.004%, is prescribed to reduce elevated intraocular pressure in patients with an open angle glaucoma or ocular hypertension.

According to IQVIA MAT March 2024, Travoprost Ophthalmic Solution USP, 0.004% (RLD Travatan Z®), had estimated annual sales of USD 77 million in the United States. So, this new product from Lupin Ltd can offer a positive result for the company.

A few weeks ago, in April 2024, Lupin received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration for its Aurangabad manufacturing facility. The inspection was conducted from March 6 to March 15, 2024. The US FDA has defined the facility’s inspection classification as Voluntary Action Indicated (VAI).

In April, the company also released Mirabegron Extended-Release Tablets, 25 mg, in the United States after getting approval from the US FDA. According to the IQVIA MAT February 2024, Mirabegron Extended-Release Tablets, 25 mg, had estimated annual sales of USD 1,019 million in the United States.

About Lupin Ltd

Lupin is an innovation-led transnational pharmaceutical company that is involved in the development and commercialisation of a comprehensive range of branded and generic formulations, biotechnology products and APIs in more than 100 markets in India, the USA, South Africa, Latin America (LATAM), the Middle East and Europe regions. The company has about 15 manufacturing facilities and 7 research centres.

On May 6, 2024, the share price of Lupin Ltd opened at ₹1,667.90 and closed at ₹1,683.10 on the NSE.

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