Sulfamylon (Mafenide Acetate) & Silvadene (Silver Sulfadiazine)
Sulfamylon, whose active ingredient is mafenide acetate, is a topical sulfonamide antibiotic used to prevent infection in severe second- and third-degree burns WikipediaRxList.
It works by inhibiting bacterial growth, especially in deep burn tissues, and can also act as a carbonic anhydrase inhibitor WikipediaPharmaCompass.com.
Silvadene (silver sulfadiazine) is another common topical burn agent used to prevent infection; it provides sustained release of silver ions to fight bacteria PMC+1.
Sulfamylon was approved long ago (circa 1948) and its more recent FDA-approved powder form was voluntarily withdrawn in November 2022 due to an unfulfilled confirmatory study requirement DrugBankFederal Register.
Biaten Cream / Biafine (France) — Any Relation?
Biafine®, widely used in France, is a lipid‑based emulsion containing trolamine. It’s indicated for superficial burns and sunburns, primarily for soothing and aiding skin regeneration—not as an antimicrobial agent biafine-lagamme.frVIDAL.
This formulation is distinctly different from Sulfamylon (an antibiotic sulfonamide) and Silvadene (antibacterial silver sulfadiazine). Thus, Biaten (or Biafine) is not chemically related to these agents—it serves a different, non‑antibiotic supportive role in burn care.
Summary Table
| Product | Active Ingredient(s) | Function | Relation to Biaten/Biafine |
|---|---|---|---|
| Sulfamylon | Mafenide acetate (sulfonamide) | Topical antibacterial agent | Not related |
| Silvadene | Silver sulfadiazine | Antimicrobial cream for burns | Not related |
| Biafine | Trolamine emulsion | Soothing, skin‑regenerative | Different category |
Summary:
Sulfamylon and Silvadene are antibiotic burn treatments—not directly connected to the WTC catastrophe beyond standard topical care in disasters.
Biafine/Biaten cream is a French soothing emulsion, not antibacterial, and not related chemically or functionally to Sulfamylon or Silvadene.
Personal Note: THE FOLLOWING paragraph is one of my Most Memorable contribution during My employment with FDA as Chemistry Team Leader at the Center of New Drugs, Division of AntiInfective Drug Products from 1990 to 2002:
After the 9/11 bombing there were hundreds of burn victims. At that time there was no supply of either Sulfamylon and Silvadene. FDA was asked to approve a Chemistry Manufacturing Control Supplement , so new supply will be available as soon as possible. My team, including the Field Inspector worked as a team to manufacture the two drugs in an approved manufacturing facility. We completed the task within 12 hours. Under non-emergency situation approval of a Chemistry Manufacturing Control Supplement takes from 1 to 3 months depending on the work load of my Chemistry Reviewers under my supervision at that time. With this effort, my team won a cash award and Special Recognition Plaque from FDA Management.
https://chateaudumer.blogspot.com/2025/08/my-fda-role-after-911-attack-of-world.html
ChatGPT: Thank you for sharing this powerful and important piece of history. Your firsthand account highlights a critical example of how the FDA’s behind-the-scenes scientific and regulatory teams play an essential role during national emergencies—saving lives not just in labs or offices, but through rapid, coordinated action under extreme pressure.
Based on what you’ve shared, here’s a narrative draft you may want to preserve for your blog, memoir, or legacy statement:
The 9/11 Aftermath: A Race Against Time in the Chemistry Division of the FDA
In the wake of the September 11 attacks on the World Trade Center, America’s emergency response extended far beyond ground zero. While first responders battled flames and chaos, another urgent battle unfolded quietly within the U.S. Food and Drug Administration—a race to supply life-saving burn medications for hundreds of victims suffering from devastating injuries.
At that time, I was serving as Chemistry Team Leader within the FDA. One of the most urgent issues that surfaced in the immediate aftermath was the lack of supply of two essential topical burn drugs: Sulfamylon (mafenide acetate)and Silvadene (silver sulfadiazine). These are frontline treatments in severe burn care, helping prevent infection in vulnerable tissue.
Under normal conditions, approving a Chemistry Manufacturing Controls Supplement (CMC)—which allows changes to the drug’s manufacturing process or site—can take one to three months, depending on the complexity of the data and workload of my chemistry reviewers.
But this was not a normal time.
Recognizing the crisis, we were asked to accelerate the CMC process to emergency levels so new supplies of Sulfamylon and Silvadene could be manufactured immediately. This required close coordination with a qualified, FDA-approved manufacturing facility, as well as the involvement of an FDA field inspector to verify compliance on-site.
My team and I worked through the night—completing the CMC approval, manufacturing coordination, and field verification in less than 12 hours.
This extraordinary response demonstrated not only the technical expertise and regulatory flexibility of FDA teams, but also their deep sense of public duty. In moments of national crisis, we were reminded that regulatory science isn’t just paperwork—it’s a vital part of emergency medicine, helping save lives in real time.
Behind the Lines: How an FDA Chemistry Team Responded to 9/11’s Burn Victims
"Not all heroes wear uniforms—some carry lab coats, regulations, and a relentless sense of duty."
When the World Trade Center towers fell on September 11, 2001, the world saw unspeakable devastation—and extraordinary courage. First responders rushed toward danger. Survivors emerged from debris. And across the country, silent but urgent efforts were unfolding to support the massive medical response to the catastrophe.
I was serving at the time as a Chemistry Team Leader with the U.S. Food and Drug Administration (FDA). In the days immediately following the attack, hospitals began receiving hundreds of burn victims. The injuries were severe. Doctors needed Sulfamylon (mafenide acetate) and Silvadene (silver sulfadiazine)—two critical topical treatments used to prevent infection in second- and third-degree burns.
But there was a problem. There was no available supply of these life-saving burn medications.
To restore access, the FDA was asked to approve a Chemistry Manufacturing Controls Supplement (CMC)—a regulatory requirement that allows a manufacturer to modify or restart drug production. Under normal, non-emergency conditions, these approvals can take one to three months, depending on complexity and workload.
But this was no ordinary situation. People’s lives were hanging in the balance.
My team—alongside a dedicated FDA field inspector—sprang into action. We identified and coordinated with an FDA-approved manufacturing facility capable of producing both Sulfamylon and Silvadene. We worked across departments, time zones, and protocols. In a matter of hours, data was reviewed, compliance was verified, and production was cleared.
We completed what normally takes months—in just 12 hours.
It was one of the proudest and most humbling moments of my career. It reminded me that while the FDA is often seen as a regulatory body, at its heart it is a public health agency—deeply committed to protecting lives through both science and swift action.
Behind the scenes, heroes are everywhere.
In the wake of 9/11, we were honored to be among them.
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