Register entryShortage reported

Avyxa GmbH

Registered sites
1
Drug products
29
Live patents
15
Countries
1
Base
Switzerland
Authorisation

Registered operations

What the FDA has registered these sites to do. This is the regulatory record, not a marketing claim.

Analytical testingLabellingFinished drug manufacturePackagingsterilize
Sites

Facilities

1
SiteLocationOperationsFEI
Avyxa GmbHBarbengoSwitzerlandAnalytical testing, Labelling, Finished drug manufacture, Packaging, sterilize3005403232
Alert

Products in shortage

2
DrugPresentationAvailability
Carboplatin InjectionKyxata, Injection, 500 mg/50 mL (10 mg/mL) (NDC 83831-142-50)Available
Carboplatin InjectionKyxata, Injection, 80 mg/8 mL (10 mg/mL) (NDC 83831-141-08)Available
Exclusivity

Patents

15

Unexpired Orange Book patents where this company is the application holder.

ProductActive ingredientExpiry
DOCIVYXDOCETAXELMar 2036
FRINDOVYXCYCLOPHOSPHAMIDEJul 2035
FRINDOVYXCYCLOPHOSPHAMIDEDec 2035
KYXATACARBOPLATINApr 2045
VYKOURALEUCOVORIN CALCIUMDec 2044
Catalogue

Marketed products

29

Showing 29 of 29.

BrandGeneric nameFormCategory
AVGEMSIGemcitabineINJECTION, SOLUTIONNDA
AVGEMSIGemcitabineINJECTION, SOLUTIONNDA
AXTLEpemetrexedINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
AXTLEpemetrexedINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
AvopefetoposideINJECTIONNDA
AvopefetoposideINJECTIONNDA
BENDAMUSTINE HYDROCHLORIDEbendamustine hydrochlorideINJECTIONNDA
CLIGAVYXfulvestrantINJECTIONNDA
CyclophosphamideCyclophosphamideINJECTIONNDA
CyclophosphamideCyclophosphamideINJECTIONNDA
CyclophosphamideCyclophosphamideINJECTIONNDA
DOCIVYXdocetaxelINJECTION, SOLUTIONNDA
DOCIVYXdocetaxelINJECTION, SOLUTIONNDA
DOCIVYXdocetaxelINJECTION, SOLUTIONNDA
FAVLYXAFluorouracilINJECTION, SOLUTIONNDA
FAVLYXAFluorouracilINJECTION, SOLUTIONNDA
FrindovyxCyclophosphamideINJECTIONNDA
FrindovyxCyclophosphamideINJECTIONNDA
FrindovyxCyclophosphamideINJECTIONNDA
KYXATACARBOplatinINJECTIONNDA
KYXATACARBOplatinINJECTIONNDA
LUTRATE DEPOTleuprolide acetateKITNDA
NAVITRUXfosaprepitantINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
PEMETREXED DIPOTASSIUMpemetrexed dipotassiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
PEMETREXED DIPOTASSIUMpemetrexed dipotassiumINJECTION, POWDER, LYOPHILIZED, FOR SOLUTIONNDA
VYKOURAleucovorin calciumINJECTIONNDA
VYKOURAleucovorin calciumINJECTIONNDA
VYKOURAleucovorin calciumINJECTIONNDA
posfreapalonosetronINJECTION, SOLUTIONNDA
Provenance

Facility and operations data from the FDA Drug Establishments Current Registration Site. Product data from the openFDA National Drug Code Directory. Patent and exclusivity data from the FDA Orange Book. Shortage data from the FDA drug shortage database. Contact details the FDA publishes for registered establishments are deliberately not reproduced here. This entry is compiled from public records and has not been claimed by the company.