Noxafil Generic Launched

September 3, 2019 – Endo Pharmaceuticals has announced the launch of its authorized generic for Merck's Noxafil® (posaconazole) 100mg delayed-release tablets. The generic received FDA approval in August 2019, and is indicated to prevent invasive Aspergillus and Candida infections in patients who are at high risk due to severely compromised immune systems.

Patients at risk include those who have received hematopoietic stem cell transplants (HSCT), who have graft-versus-host disease (GVHD, in which transplanted stem cells attack the body), or who have hematologic malignancies (cancers that affect the blood and blood-forming organs) with prolonged neutropenia (low white blood cell counts) from chemotherapy. Each of these conditions, as well as others, can leave patients with a weakened immune system, allowing organisms that are ordinarily harmless to cause serious infection. Aspergillus is a genus of mold species with spores typically present in the air, while Candida is a genus of yeast commonly present in the environment. Infections caused by these organisms are known as aspergillosis and candidiasis, and are considered fungal diseases.

Posaconazole delayed-release tablets have a recommended loading dose of 300mg (three 100mg tablets) taken twice on the first day. Recommended maintenance dosing is 300mg once daily starting the second day, with the duration of treatment dependent on recovery from neutropenia or immunosuppression. The tablets should be taken with food and used only for prophylaxis (prevention) of infection.

Although there is an oral suspension form of Noxafil, it is not interchangeable with the posaconazole delayed-release tablets and carries an additional indication to treat candidiasis. The oral suspension remains brand-only, as does an injectable dosage form of Noxafil indicated for prophylaxis of aspergillosis and candidiasis.

Endo's authorized generic is available at a wholesale acquisitions cost (WAC) of $3,289.44 per 60 tablets, compared to $4,111.80 for the brand name tablets.