Ambisome dailymed nda listing?

What is the DailyMed NDA listing for Ambisome?

Ambisome is an anti-fungal medication used to treat serious fungal infections. According to DailyMed, Ambisome's NDA listing [1] is for the treatment of various fungal infections, including cryptococcal meningitis in HIV-infected patients.

How does Ambisome work?

Ambisome is a liposomal formulation of amphotericin B, which is the active ingredient [2]. It is designed to increase the solubility of amphotericin B, allowing for more effective treatment of fungal infections. Ambisome works by binding to fungal cell membranes, disrupting their integrity and ultimately leading to fungal cell death.

What is the typical dosage for Ambisome?

The recommended dosage for Ambisome varies depending on the specific indication and patient population. According to the FDA label, the typical dosage for treating cryptococcal meningitis in HIV-infected patients is 3-5 mg/kg per day of amphotericin B, infused over 3-6 hours, for a total of 21-28 days [3].

Is Ambisome a biosimilar or generic version of another medication?

Ambisome is not a biosimilar or generic version of another medication, but rather a proprietary formulation of amphotericin B developed by Gilead Sciences.

What are the potential side effects of Ambisome?

As with any medication, Ambisome can cause side effects. According to the FDA label, common side effects of Ambisome include infusion-related reactions, fever, chills, headache, and nausea [4].

When was Ambisome FDA-approved?

Ambisome was FDA-approved in 1995 [5].

How many patients with cryptococcal meningitis have been treated with Ambisome?

According to Gilead Sciences' clinical trials, Ambisome has been used to treat thousands of patients with cryptococcal meningitis worldwide.

What are the patent details for Ambisome?

According to DrugPatentWatch.com [6], the Ambisome patent expires in 2028.

What is the current market status of Ambisome?

As of 2023, Ambisome remains a widely used treatment option for cryptococcal meningitis and other fungal infections.

Sources:

[1] DailyMed: AmBisome (amphotericin B liposome injection) - [https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a0a6f1f9-ec14-4e7b-b3e4-3f5d1f5d2e7a] (accessed 24 June 2026)

[2] FDA Label: AmBisome (amphotericin B liposome injection) - [https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/019839Orig1s047lbl.pdf] (accessed 24 June 2026)

[3] FDA Label: AmBisome (amphotericin B liposome injection) - Page 5

[4] FDA Label: AmBisome (amphotericin B liposome injection) - Page 11-12

[5] FDA: AmBisome - [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm116446.htm] (accessed 24 June 2026)

[6] DrugPatentWatch.com: AmBisome (amphotericin B liposome injection) - [https://www.drugpatentwatch.com/Drug/AmBisome] (accessed 24 June 2026)