Shilpa Medicare gets USFDA approval for lung cancer injection Pemetrexed
Pemetrexed injection is used in the treatment of Non-small cell lung cancer and Malignant pleural mesothelioma as approved in the Prescribing Information.;
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Karnataka: Shilpa Medicare has announced that the company’s New Drug Application for Pemetrexed Injection 1000 mg/100 ml, 500 mg/50 ml & 100 mg/10 ml, Ready to Use formulation is approved by US Food and Drug Administration (US FDA).
This is the first NDA product approval received by the Company under 505(b)(2) application, which is a unique formulation supplied as ready to use product solution. This product is required to be administered intravenously without any further dilution. The product is stable at room temperature. The company has developed Pemetrexed formulation as liquid/ ready to use injection against Lyophilized powder formulation of reference ALIMTA.
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