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Notice to the Market – New regulatory approvals


Grupo Biotoscana announces new approvals

Montevideo, Uruguay, October 4, 2018. GBT-Grupo Biotoscana (B3: GBIO33), a leading biopharmaceutical company in Latin America, announces to its shareholders and the market in general that it has received new regulatory approvals for three products – CRESEMBA® (isavuconazole), BUSILVEX® (busulfan) and AMBISOME® (amphotericin B).

The antifungal CRESEMBA® was approved by ANMAT in Argentina for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. The product is a well differentiated drug that addresses a critical medical need in patients with invasive mold infections.

BUSILVEX® was approved in Chile as conditioning treatment prior to hematopoietic progenitor cell transplantation (HPCT) under three different conditions. Firstly, BUSILVEX® can be used followed by cyclophosphamide as conditioning treatment prior to HPCT in adult patients, when the combination is considered the best available option. It can also be used following fludarabine as conditioning treatment prior to HPCT in adult candidates for a reduced intensity conditioning regimen. In pediatric patients, BUSILVEX® is used followed by cyclophosphamide or melphalan.

The registration transfer of AMBISOME® was approved in Peru. AMBISOME® is approved for the empirical therapy for presumed fungal infection in febrile, neutropenic patients, treatment of Cryptococcal Meningitis in HIV infected patients, treatment of patients with Aspergillus species, Candida species and/or Cryptococcus species infections refractory to amphotericin B deoxycholate, or in patients where renal impairment or unacceptable toxicity precludes the use of amphotericin B deoxycholate and treatment of visceral leishmaniasis. GBT also holds licensing rights to AMBISOME® in Brazil, Bolivia and Paraguay.

GBT is committed to maximizing the value of our portfolio and increasing the benefits provided to patients as well as healthcare providers.

GBT – Grupo Biotoscana.

To access the PDF version, please click here.

Updated on 01/02/2019 at 04:26 pm