SangCya

SangCya

Oncology A formulation of cyclosporine, an immunosuppressant for preventing rejection in transplants, rheumatoid arthritis, plaque psoriasis. See Cyclosporine.
Mentioned in ?
References in periodicals archive ?
For example, SangCya oral solution, a generic cyclosporine-modified product, was taken off the market because it was not bioequivalent when taken in apple juice; this was problematic because apple juice was a popular vehicle for the oral solution for children.
They had secured an approval for a drug SangCya, saying it was similar to an old Novartis drug Sandimmun.
It should be noted, however, that the first generic compound of Neoral was SangCyA.
SangStat also announced it will terminate all clinical development programs for SangCya Oral Solution, CycloTech and diagnostic or monitoring products.
To this end, all clinical development programs for SangCya Oral Solution, CycloTech and diagnostic or monitoring products have been terminated.
In the suit, Novartis claimed that SangStat's oral solution, SangCya, employs a cyclosporine technology invented and patented by Novartis but not used in Novartis' innovative microemulsion product, Neoral (cyclosporine, USP MODIFIED).
Other factors that could cause actual results to differ materially include, without limitation, the expenses associated with and uncertainty related to the lawsuits pending against the MCA by Novartis with respect to SangCya oral solution, which could impact the regulatory approval of any cyclosporine capsule as well.
Novartis Pharmaceuticals Corporation has announced it has developed a monitoring program to support the "safe and responsible conversion" of transplant recipients on SangStat's SangCya (cyclosporine oral solution, USP [MODIFIED], to Neoral.
The US Food and Drug Administration (FDA) announced on July 10 that the SangStat Medical Corporation, Fremont, CA, has agreed to recall all lots of SangCya oral solution because of clinical evidence that the generic drug is not bioequivalent to Novartis AG's Neoral oral solution when mixed with apple juice as recommended in its labeling.
The two companies also currently co-promote SangStat's liquid cyclosporine, SangCya.
On March 31 a British court denied an attempt by Novartis to have the UK marketing authorization of SangStat UK's SangCya Organ Solution revoked.
As part of the settlement, SangStat has acknowledged that the Novartis patents are valid, but SangStat continues to believe that SangCya does not infringe these patents.