The Kevzara Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s dive into the journey of Kevzara (sarilumab) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Kevzara (sarilumab) Mechanism of Action: IL-6 receptor antagonist, which helps reduce […]
The Addyi Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Addyi (flibanserin) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Addyi (flibanserin) Mechanism of Action: Serotonin 1A receptor agonist and […]
The Jardiance Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Jardiance (empagliflozin) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case study provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Jardiance (empagliflozin) Mechanism of Action: Sodium-glucose co-transporter 2 (SGLT2) inhibitor, which […]
The Brilinta Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s delve into the journey of Brilinta (ticagrelor) from receiving an FDA Complete Response Letter (CRL) to achieving approval. Understanding this case provides valuable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Brilinta (ticagrelor) Mechanism of Action: P2Y12 receptor antagonist, which inhibits […]