Shilpa Medicare’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 FDA, the company announced through an exchange filing.
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. The product approval has been received for the application filed from a third party manufacturing site. The Company has already entered into a commercialization agreement with Amneal Pharmaceuticals LLC for the US Market.
Pemetrexed injection is used in the treatment of Non-small cell lung cancer & Malignant pleural mesothelioma as approved in the Prescribing Information.
According to IQVIA MAT Q1 2023 data, the US market for Pemetrexed Injection is approximately USD 735.3 Million.
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