It is possible to get Fludara (fludarabine) as a generic product. These generic versions come in two strengths and are made by various companies, including Sandoz, Hospira, and Sargent Pharmaceuticals. The Food and Drug Administration has determined that these generic Fludara products are equivalent to the brand-name medicine. However, the generics may contain different inactive ingredients than the brand-name drug.
Fludara® (fludarabine phosphate) is a prescription chemotherapy medication used to treat chronic lymphocytic leukemia that has not improved, or has progressed, despite treatment with certain other chemotherapy medicines. It belongs to a group of medicines known as purine analogs.
Fludara is made by Ben Venue Laboratories for Genzyme Corporation. The drug is no longer protected from generic competition by patents and is available as a generic.
Generic Fludara is available in the following strengths:
- Fludarabine phosphate 25 mg per mL vial (liquid)
- Fludarabine phosphate 50 mg per vial (dry powder that is to be mixed with an appropriate liquid).
Generic Fludara is made by several different companies, including:
- APP Pharmaceutical
- Bioniche Pharma USA
- Pfizer US Pharmaceutical Group
- Sargent Pharmaceuticals, Inc.
- Teva Pharmaceuticals USA.
All generic medications must undergo certain tests to compare them to brand-name medications. The U.S. Food and Drug Administration (FDA) then looks at these tests to decide if the generics are equivalent to the brand-name medications and assigns each generic a rating.
An "AP" rating means that the FDA has determined that a generic injectable medication is equivalent to a brand-name medication. All of the generic Fludara versions currently available have an "AP" rating, meaning they should be equivalent to Fludara.
However, generic medications are allowed to have different inactive ingredients than the brand-name medication. This might include fillers, dyes, or other ingredients that may cause problems for people with allergies or sensitivities.