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ForDoz Secures US FDA Approval for Doxorubicin Hydrochloride Liposome Injection

ForDoz Secures US FDA Approval for Doxorubicin Hydrochloride Liposome Injection

Lupin has announced that its alliance partner, ForDoz Pharma Corp. has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application for Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials, to market a generic equivalent of Doxil Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL), of Baxter Healthcare Corporation.

Doxorubicin Hydrochloride Liposome Injection, 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials are indicated for the treatment of ovarian cancer, acquired immune deficiency syndrome (AIDS)-related Kaposi’s Sarcoma, and multiple myeloma.

Doxorubicin Hydrochloride Liposome Injection (RLD Doxil) had estimated annual sales of USD 42 million in the US.

Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products, and APIs in over 100 markets in the US, India, South Africa, and across the Asia Pacific (APAC), Latin America (LATAM), Europe, and Middle East regions.

More news about: global pharma | Published by Aishwarya | July - 22 - 2024 | 118

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