Zydus Cadila receives final approval from USFDA to market Doxorubicin Hydrochloride Liposome Injection


Zydus Cadila, part of Cadila Healthcare Group has reportedly received final approval from the USFDA to market Doxorubicin Hydrochloride Liposome Injection in the strengths of 20 mg/10 mL (2 mg/mL) and 50 mg/25 mL (2 mg/mL) Single-Dose Vials respectively. This is the group’s first approval for a complex injectable which has been developed in-house and will be manufactured at group’s facility located in Special Economic Zone (SEZ).

According to IQVIA, the company’s injectable portfolio has 39 products under development with addressable market size of $20bn. US sales for Liposomal Doxorubicin Injection were approximately $124 million for the 12 months ending July 2020.

Sharvil Patel, Managing Director, Zydus Cadila said in a release, “This FDA approval of Liposomal Doxorubicin Injection demonstrates our long-term commitment to drive growth through investment in complex generic products. The approval further builds on Zydus’ proven track-record of successfully commercializing and gaining meaningful market share in complex generics products, we expect our long term investment reap dividends, as we create an industry leading portfolio of complex products.”

“Through this investment, we have created a diversified portfolio of complex ANDAs. This portfolio provides continued opportunities to grow our US business in 2021 and beyond,” he added.

“Zydus, with its focus on innovation and long term investments, has created an industry leading portfolio of complex injectable products, drug device combination products, topicals, transdermal patches, difficult-to-develop solid oral products and first-to-file products,” stated the release.

Liposomal doxorubicin is a chemotherapeutic agent that is used alone or with other treatments/medications to treat certain types of cancer such as ovarian cancer, AIDS-related Kaposi’s sarcoma and multiple myeloma. It works by slowing or stopping cancer cell growth. “The group now has 300 approvals and has so far filed over 390 ANDAs since the commencement of the filing process in FY 2003-04,” the release added.


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