Zydus Cadila gets USFDA gesture to showcase its disease treatment infusion
- Post By : Kumar Jeetendra
- Source: PTI
- Date: 11 Sep,2020
New Delhi, Sep 11 (PTI) Medication firm Zydus Cadila on Friday said it has received final nod in the US health regulator to advertise its generic Doxorubicin Hydrochloride Liposome injection, used for treatment of certain types of cancer, in the American market.
The company has received final approval from the United States Food and Drug Administration (USFDA) to advertise Doxorubicin Hydrochloride Liposome injection from the strengths of 20 mg/10 mL (two mg/mL) and 50 mg/25 mL (two mg/mL) single-dose vials, Zydus Cadila said in a statement.
This is the group”s first approval for a complex injectable that has been developed in-house and will be fabricated at the group”s facility, it added.
According to IQVIA, the US sales for Liposomal Doxorubicin injection were roughly USD 124 million (about Rs 910 crore) for the 12 months ending July 2020, Zydus Cadila stated.
“This FDA approval of Liposomal Doxorubicin injection shows our long-term devotion to drive growth through investment in complicated generic products,” Zydus Cadila MD Sharvil Patel said.
“Through this investment, we’ve made a diversified portfolio of complicated abbreviated new drug applications (ANDAs). This portfolio offers continued opportunities to grow our US company in 2021 and beyond,” he added.
Liposomal Doxorubicin is a chemotherapeutic agent that is used alone or with other treatments/medications to treat certain forms of cancer such as ovarian cancer, AIDS-related Kaposi”s sarcoma and multiple myeloma.
It works by slowing or stopping cancer cell development, the statement said.
The team now has 300 approvals and has so far registered over 390 ANDAs since the commencement of its filing process, it added.
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