United States — Food and Drug Administration & Lupin (company)

United States — Food and Drug Administration: The United States — Food and Drug Administration granted tentative approval for Lupin (company)'s Enzalutamide Tablets, acting as the regulatory body overseeing drug approvals in the U.S.

Lupin (company): Lupin (company) received tentative approval from the U.S. FDA for its Enzalutamide Tablets, which is a positive development for the company as it expands its product offerings and market reach.

United States — Food and Drug Administration: The FDA classified the recall as Class II and issued public notices, reinforcing its regulatory oversight role.

Lupin (company): Lupin (company) is the manufacturer of the recalled eye drops; the recall may harm its brand and lead to potential liability, though the company is cooperating voluntarily.

United States — Food and Drug Administration: The FDA granted approval to Lupin's ANDA, demonstrating its role as the regulatory authority in the U.S. pharmaceutical market.

Lupin (company): Lupin received FDA approval for its generic Pitolisant tablets, which is a positive development for its U.S. business and may lead to increased sales and market share.

United States — Food and Drug Administration: The United States — Food and Drug Administration granted approval for Eribulin Mesylate Injection, enabling Lupin (company) and Natco Pharma to market a generic alternative in the U.S.

Lupin (company): Lupin (company), in partnership with Natco Pharma, received U.S. FDA approval for Eribulin Mesylate Injection, which is expected to provide a competitive edge in the oncology market and contribute to its sales.

United States — Food and Drug Administration: The FDA's approval of YUVEZZI is a prerequisite for its U.S. commercialization and adds credibility to the product.

Lupin (company): Lupin, through its subsidiary VISUfarma, secures exclusive rights to commercialize YUVEZZI in key European Union — European markets, strengthening its ophthalmology franchise and specialty care strategy. The deal includes a strategic investment and potential milestone payments, which could enhance future revenue.

United States — Food and Drug Administration: The FDA noted that generics constitute over 90% of US prescriptions, highlighting the policy's broad impact.

Lupin (company): Lupin is a major generic drug supplier to the US; the tariff plan poses a risk to its US market share.