Categories: Uncategorized

Glenmark gets US FDA nod for Icatibant injection, 30 mg/3 mL (10 mg/mL) single-dose prefilled syringe

Glenmark Pharmaceuticals 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 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.

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’s current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 ANDA’s pending approval with the US FDA.

Medically Speaking Team

Recent Posts

Harness the Power of Rice Water

Rice water, rich in inositol, antioxidants, vitamins, and minerals, protects hair from sunlight damage and…

11 hours ago

“8 Powerful Herbs and Supplements to Beat Bloating and Boost Your Gut Health Naturally”

Natural Remedies for Bloating: 8 Herbs and Supplements That Work Wonders for Your Gut Health…

11 hours ago

“Unlock the Power of Oil Pulling: Discover How This Simple Practice Improves Oral Health and Freshens Your Breath”

Benefits of Oil Pulling: Stops Bad Breath, Keeps Gums Healthy, But Can't Replace Brushing Oil…

12 hours ago

WHY DO YOU EXPERIENCE RUNNY NOSE AFTER EATING SPICY FOOD?

Spicy food – whether it’s a dash of chili in your curry, a spoonful of…

12 hours ago

“4 Simple Tests to Spot Adulterated Wheat Flour: Protect Your Health with These Easy Checks”

How To Identify Adulterated Wheat Flour? Try These 4 Easy Tests Wheat flour is a…

12 hours ago

“Unlock the Power of Jaggery: 10 Surprising Health Benefits of Eating It After Every Meal”

Reasons That Will Make You Eat Jaggery After Every Meal (Potential Health Benefits Inside) Jaggery,…

12 hours ago