Looking over the daily COVID-19 updates from the FDA (here), I noticed that the OGD had approved “two generic drugs indicated to facilitate tracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation: succinylcholine chloride injection USP 200 mg/10 mL and cisatracurium besylate injection USP 20 mg/10 mL.” Glad to see that the Agency is nimble so it can react to shortage issues.
However, the approval for succinylcholine chloride injection USP 200 mg/10 mL caught my eye. The spark that triggered in my brain (or what is left of it after six weeks of quarantine) was the ANDA number, 213810. Why? Well, because, if you do some tricky calculations, you can get a rough estimate of when the ANDA was filed. After some finger pounding on various FDA databases, it appears that the ANDA was submitted to the FDA in December 2019 or shortly thereafter (difficult to nail down an exact window without seeing the approval letter, which is not yet posted, because the OGD preassigns ANDA numbers). In addition, according to the Orange Book, this is the first approval for this Indian company under its name.
This is a remarkable feat as most new companies’ first ANDAs typically go through multiple review cycles. So, the OGD was able to approve this product somewhere in the neighborhood of four to five months. That, my friend, is lightning speed at the FDA, and kudos to the OGD, OPQ, and the rest of the FDA’s machinery that moved so quickly to help relieve the drug shortage for this critical ICU/ER medication.
