Zydus Cadila gains on getting USFDA nod for Doxorubicin Hydrochloride Liposome injection
Zydus Cadila has received final approval from 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.
This is the group’s first approval for a complex injectable that has been developed in-house and will be manufactured at the group’s facility located in SEZ. The company’s injectable portfolio has 39 products under development with addressable market size of USD 20 billion. The US sales for Liposomal Doxorubicin injection were approximately USD 124 million for the 12-month ending July 2020, according to IQVIA.
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 helps in slowing or stopping cancer cell growth.
The group now has 300 approvals and has so, far filed over 390 ANDAs.
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