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Pharmaceuticals
USFDA12 Aug 2025, 01:04 pm

Gland Pharma Receives USFDA Approval for Cangrelor for Injection

AI Summary

Gland Pharma Limited has received approval from the USFDA for its Abbreviated New Drug Application for Cangrelor for Injection 50mg/vial. The product is bioequivalent and therapeutically equivalent to the reference listed drug, KENGREAL of Chiesi USA Inc. It is indicated for an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis in patients who have not been treated with a P2Y12 platelet inhibitor and are not being given a glycoprotein Ib/Illa inhibitor. Gland Pharma is eligible for 180 days of generic drug exclusivity. The product had US sales of approximately USD 122 million for the twelve months ending June 2025.

Key Highlights

  • Gland Pharma receives USFDA approval for Cangrelor for Injection 50 mg/vial
  • Product is bioequivalent and therapeutically equivalent to the reference listed drug, KENGREAL of Chiesi USA Inc
  • Indicated for an adjunct to percutaneous coronary intervention for reducing the risk of periprocedural myocardial infarction, repeat coronary revascularization, and stent thrombosis
  • Gland Pharma is eligible for 180 days of generic drug exclusivity
  • Product had US sales of approximately USD 122 million for the twelve months ending June 2025
GLAND
Pharmaceuticals
Gland Pharma Ltd

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