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| Site | Location | Operations | FEI |
|---|---|---|---|
| Avyxa GmbH | BarbengoSwitzerland | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3005403232 |
Alert
Products in shortage
2| Drug | Presentation | Availability |
|---|---|---|
| Carboplatin Injection | Kyxata, Injection, 500 mg/50 mL (10 mg/mL) (NDC 83831-142-50) | Available |
| Carboplatin Injection | Kyxata, Injection, 80 mg/8 mL (10 mg/mL) (NDC 83831-141-08) | Available |
Exclusivity
Patents
15Unexpired Orange Book patents where this company is the application holder.
| Product | Active ingredient | Expiry |
|---|---|---|
| DOCIVYX | DOCETAXEL | Mar 2036 |
| FRINDOVYX | CYCLOPHOSPHAMIDE | Jul 2035 |
| FRINDOVYX | CYCLOPHOSPHAMIDE | Dec 2035 |
| KYXATA | CARBOPLATIN | Apr 2045 |
| VYKOURA | LEUCOVORIN CALCIUM | Dec 2044 |
Catalogue
Marketed products
29Showing 29 of 29.
| Brand | Generic name | Form | Category |
|---|---|---|---|
| AVGEMSI | Gemcitabine | INJECTION, SOLUTION | NDA |
| AVGEMSI | Gemcitabine | INJECTION, SOLUTION | NDA |
| AXTLE | pemetrexed | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| AXTLE | pemetrexed | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| Avopef | etoposide | INJECTION | NDA |
| Avopef | etoposide | INJECTION | NDA |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | INJECTION | NDA |
| CLIGAVYX | fulvestrant | INJECTION | NDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION | NDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION | NDA |
| Cyclophosphamide | Cyclophosphamide | INJECTION | NDA |
| DOCIVYX | docetaxel | INJECTION, SOLUTION | NDA |
| DOCIVYX | docetaxel | INJECTION, SOLUTION | NDA |
| DOCIVYX | docetaxel | INJECTION, SOLUTION | NDA |
| FAVLYXA | Fluorouracil | INJECTION, SOLUTION | NDA |
| FAVLYXA | Fluorouracil | INJECTION, SOLUTION | NDA |
| Frindovyx | Cyclophosphamide | INJECTION | NDA |
| Frindovyx | Cyclophosphamide | INJECTION | NDA |
| Frindovyx | Cyclophosphamide | INJECTION | NDA |
| KYXATA | CARBOplatin | INJECTION | NDA |
| KYXATA | CARBOplatin | INJECTION | NDA |
| LUTRATE DEPOT | leuprolide acetate | KIT | NDA |
| NAVITRUX | fosaprepitant | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| PEMETREXED DIPOTASSIUM | pemetrexed dipotassium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| PEMETREXED DIPOTASSIUM | pemetrexed dipotassium | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | NDA |
| VYKOURA | leucovorin calcium | INJECTION | NDA |
| VYKOURA | leucovorin calcium | INJECTION | NDA |
| VYKOURA | leucovorin calcium | INJECTION | NDA |
| posfrea | palonosetron | INJECTION, SOLUTION | NDA |
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.