Glenmark receives US FDA approval for Icatibant Injection
Glenmark receives US FDA approval for Icatibant Injection
25 May 2021 | News The injection will be manufactured in their North American manufacturing facility based in Monroe, North Carolina
Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr 1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies. This marks Glenmark s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.
Read more about Glenmark receives USFDA approval for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe on Business Standard. According to IQVIA™ sales data for the 12 month period ending March 2021, the Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market achieved annual sales of approximately $223.4 million.
Glenmark Pharma gets USFDA nod for Icatibant injection
By IANS |
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Glenmark launches nasal spray for allergic rhinitis in India. Image Source: IANS News
Chennai, May 24 : Pharma major Glenmark Pharmaceuticals Limited on Monday said it has received the final approval from the United States Food & Drug Administration (USFDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe.
The injection is the generic version of Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies, Inc.
According to Glenmark, this is the company s first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina.