Medicine
Avmapki Fakzynja Co-pack kit
Avmapki Fakzynja Co-pack kit is a prescription medicine containing Avutometinib and Defactinib, marketed by Verastem, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians. It ships in a temperature-controlled cold chain.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Cold chain
Store AVMAPKI capsules and FAKZYNJA tablets refrigerated at 2°C to 8°C (36°F…
Key facts
- Active ingredient (INN)
- Avutometinib and Defactinib
- Brand
- Avmapki Fakzynja Co-pack
- Dosage form
- Kit
- Packs
- 1 kit
- Marketing authorisation holder
- Verastem
- Manufacturer
- Verastem
- Origin register
- US FDA, United States
- Storage
- Store AVMAPKI capsules and FAKZYNJA tablets refrigerated at 2°C to 8°C (36°F to 46°F) in their original bottles.
- Cold chain
- Yes, shipped temperature controlled
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 8 May 2025
- Identifiers
- RxCUI 2714507, 2714513, 2714520 +3DailyMed set ID 65889527-1406-45df-8a85-e2690dcf427dNDC 71779-623Application NDA219616
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 1 kit in 1 carton * 24 capsule in 1 bottle * 42 tablet in 1 bottle | 71779-623-01 | Verastem | 8 May 2025 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
| Register | Status | Source |
|---|---|---|
| US FDA | Listed, marketed | Source record for this pageChecked 12 November 2026 |
| US FDA | First approved 8 May 2025 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Clinical summary
Avutometinib and Defactinib is a fixed-dose combination medicine indicated for the treatment of adult patients with KRAS -mutated recurrent low-grade serous ovarian cancer (LGSOC) who have received prior systemic therapy. It is available as kits. MedsAcross supplies Avutometinib and Defactinib for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about Avutometinib and DefactinibFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- AVMAPKI FAKZYNJA CO-PACK prescribing information (Verastem) · U.S. National Library of Medicine, DailyMed
Need Avmapki Fakzynja Co-pack kit for your hospital or patient?
Send one request with the destination country and quantity. We confirm availability, lead time and the documents your regulator needs.