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Shilpa Medicare gets USFDA approval for zoledronic acid injection

Shilpa Medicare has received US Food and Drug Administration (USFDA) final approval for its ANDA, zoledronic acid injection, 4 mg/5 mL. Zoledronic acid injection, 4 mg/5 ml is a generic equivalent of reference listed drug (RLD) Zometa. It is a bisphosphonate indicated for the treatment of hypercalcemia of malignancy, patients with multiple myeloma, and patients with documented bone metastases from solid tumors, in conjunction with standard antineoplastic therapy as recommended in the label approved by FDA.

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