Register entryShortage reported
- Registered sites
- 1
- Active NDC listings
- 29
- Labeller names
- 2
- Live patents
- 17
- Shortage listings
- 2
- Countries
- 1
- Base
- Switzerland
Authorisation
Registered operations
Analytical testing1Labelling1Finished drug manufacture1Packaging1sterilize1
Sites
Registered establishments
1| Establishment | Address | Registered for | FEI / DUNS |
|---|---|---|---|
| Avyxa GmbH | Via Cadepiano 24, Barbengo, Ticino 6917, Switzerland (CHE) | Analytical testing, Labelling, Finished drug manufacture, Packaging, sterilize | 3005403232482730327 |
Alert
Drug shortage listings
2| Drug | Presentation | Status | Availability | Posted / updated |
|---|---|---|---|---|
| Carboplatin InjectionOncology | Kyxata, Injection, 500 mg/50 mL (10 mg/mL) (NDC 83831-142-50) | Current | Available | 28 Apr 20231 Sept 2026 |
| Carboplatin InjectionOncology | Kyxata, Injection, 80 mg/8 mL (10 mg/mL) (NDC 83831-141-08) | Current | Available | 28 Apr 20231 Sept 2026 |
Catalogue
Drug listings by form and route
2929 active NDC listings: 29 human prescription drug. By marketing category: NDA 29.
| Dosage form | NDCs |
|---|---|
| injection | 15 |
| injection, solution | 8 |
| injection, powder, lyophilized, for solution | 5 |
| kit | 1 |
| Route | NDCs |
|---|---|
| intravenous | 27 |
| intramuscular | 4 |
| Labeller name on the listing | NDCs |
|---|---|
| avyxa pharma, llc | 23 |
| avyxa pharma, llc | 6 |
Exclusivity
Patents and exclusivities
17| Patent | Product | Covers | Expiry |
|---|---|---|---|
| 10849916 | FRINDOVYXcyclophosphamide | product | Jul 2035 |
| 11382923 | FRINDOVYXcyclophosphamide | product | Dec 2035 |
| 10398785 | DOCIVYXdocetaxel | product | Mar 2036 |
| 12564592 | VYKOURAleucovorin calcium | product | Dec 2044 |
| 12427104 | KYXATAcarboplatin | product | Apr 2045 |
| 12721811 | AXTLEpemetrexed dipotassium | product | Jun 2045 |
Catalogue
Marketed products
29| Brand | Generic name | Form / route | NDC |
|---|---|---|---|
| AVGEMSI | Gemcitabine | injection, solution, intravenous | 83831-123NDA |
| AVGEMSI | Gemcitabine | injection, solution, intravenous | 83831-124NDA |
| AXTLE | pemetrexed | injection, powder, lyophilized, for solution, intravenous | 83831-131NDA |
| AXTLE | pemetrexed | injection, powder, lyophilized, for solution, intravenous | 83831-132NDA |
| Avopef | etoposide | injection, intravenous | 83831-144NDA |
| Avopef | etoposide | injection, intravenous | 83831-145NDA |
| BENDAMUSTINE HYDROCHLORIDE | bendamustine hydrochloride | injection, intravenous | 83831-183NDA |
| CLIGAVYX | fulvestrant | injection, intramuscular | 83831-159NDA |
| Cyclophosphamide | Cyclophosphamide | injection, intravenous | 83831-116NDA |
| Cyclophosphamide | Cyclophosphamide | injection, intravenous | 83831-117NDA |
| Cyclophosphamide | Cyclophosphamide | injection, intravenous | 83831-118NDA |
| DOCIVYX | docetaxel | injection, solution, intravenous | 83831-101NDA |
| DOCIVYX | docetaxel | injection, solution, intravenous | 83831-102NDA |
| DOCIVYX | docetaxel | injection, solution, intravenous | 83831-103NDA |
| FAVLYXA | Fluorouracil | injection, solution, intravenous | 83831-143NDA |
| FAVLYXA | Fluorouracil | injection, solution, intravenous | 83831-164NDA |
| Frindovyx | Cyclophosphamide | injection, intravenous | 83831-119NDA |
| Frindovyx | Cyclophosphamide | injection, intravenous | 83831-120NDA |
| Frindovyx | Cyclophosphamide | injection, intravenous | 83831-121NDA |
| KYXATA | CARBOplatin | injection, intravenous | 83831-141NDA |
| KYXATA | CARBOplatin | injection, intravenous | 83831-142NDA |
| LUTRATE DEPOT | leuprolide acetate | kit | 83831-134NDA |
| NAVITRUX | fosaprepitant | injection, powder, lyophilized, for solution, intravenous | 83831-153NDA |
| PEMETREXED DIPOTASSIUM | pemetrexed dipotassium | injection, powder, lyophilized, for solution, intravenous | 83831-111NDA |
| PEMETREXED DIPOTASSIUM | pemetrexed dipotassium | injection, powder, lyophilized, for solution, intravenous | 83831-112NDA |
| VYKOURA | leucovorin calcium | injection, intramuscular, intravenous | 83831-147NDA |
| VYKOURA | leucovorin calcium | injection, intramuscular, intravenous | 83831-148NDA |
| VYKOURA | leucovorin calcium | injection, intramuscular, intravenous | 83831-149NDA |
| posfrea | palonosetron | injection, solution, intravenous | 83831-105NDA |
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Enquiry
Common questions
- Is Avyxa GmbH FDA approved?
- Avyxa GmbH holds 1 FDA-registered establishment in Switzerland. Registration puts a site on the FDA's register and open to inspection; it is not an approval of the company. Approvals attach to individual drug applications.
- Where are Avyxa GmbH's drugs manufactured?
- The FDA register lists Barbengo. Registered operations: analytical testing, labelling, finished drug manufacture, packaging, sterilize.
- What drugs does Avyxa GmbH make?
- 29 products are listed under Avyxa GmbH in the openFDA NDC Directory, most often as injection; injection, solution; injection, powder, lyophilized, for solution. The full breakdown by dosage form and route is above. A listing count is not a sales figure.
- Are any Avyxa GmbH products in shortage?
- 2 presentations are currently listed in the FDA drug shortage database under Avyxa GmbH, covering Carboplatin Injection.
Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.