Mayne Pharma gets FDA nod for Tolsura
Mayne Pharma Group has received clearance from the Food and Drug Administration for Tolsura (SUBA-itraconazole, 65-mg capsules).
Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.
The product is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are resistant to amphotericin B therapy.
These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.
"We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma's proprietary SUBA technology to improve the bioavailability of poorly soluble drugs. Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes. We are proud to offer a new treatment option for patients with these life-threatening infections,"Mayne Pharma’s CEO Scott Richards said.
Anti-fungal triazole has a market value of $600 million, according to IQVIA data.
Tolsura is a new formulation of itraconazole indicated for the treatment of certain systemic fungal infections in adult patients.
The product is indicated for the treatment of blastomycosis (pulmonary and extrapulmonary), histoplasmosis (including chronic cavitary pulmonary disease and disseminated, non-meningeal histoplasmosis) and aspergillosis (pulmonary and extrapulmonary, in patients who are intolerant of or who are resistant to amphotericin B therapy.
These serious infections most commonly occur in vulnerable or immunocompromised patients, for example, those with a history of cancer, transplants (solid organ or bone marrow), HIV/AIDS, or chronic rheumatic disorders, and are often associated with high mortality rates or long-term health issues.
"We are very pleased to have received FDA approval of this patented formulation of itraconazole which incorporates Mayne Pharma's proprietary SUBA technology to improve the bioavailability of poorly soluble drugs. Reformulation of existing drugs plays an important role in improving patient compliance and clinical outcomes. We are proud to offer a new treatment option for patients with these life-threatening infections,"Mayne Pharma’s CEO Scott Richards said.
Anti-fungal triazole has a market value of $600 million, according to IQVIA data.