The Vyleesi Resubmission Journey: From FDA CRL to Approval
Hello Regulatory Scientists, Today, let’s explore the journey of Vyleesi (bremelanotide) 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: Vyleesi (bremelanotide) Mechanism of Action: Melanocortin receptor agonist, which activates melanocortin receptors […]
The Farxiga Resubmission Journey: Turning an FDA CRL into Success
Hello Regulatory Scientists, Today, let’s explore the journey of Farxiga (dapagliflozin) from receiving an FDA Complete Response Letter (CRL) to achieving approval. This case provides invaluable insights and lessons that can guide companies developing new drugs today. Regulatory History and Initial Submission Drug: Farxiga (dapagliflozin) Mechanism of Action: Sodium-glucose co-transporter 2 (SGLT2) inhibitor Indication: Type […]