HSP

The Food and Drug Administration Tuesday said it approved two new suppliers of two cancer drugs that are currently in short supply.

Specifically, the agency said it would allow the temporary importation of a drug called Lipodox to address a shortage of Johnson & Johnson's (JNJ) Doxil. It also approved APP Pharmaceuticals to make a preservative-free methotrexate, a drug used to treat a type of children's leukemia.

Supplies of both drugs started running low after Ben Venue Laboratories, a division of Boehringer Ingelheim GmbH, shut down a manufacturing plant in Ohio in November to address manufacturing problems with some products. Ben Venue makes Doxil for Johnson & Johnson and was among the larger suppliers of a preservative-free version of methotrexate, which doctors say is the primary treatment for children with acute lymphocytic leukemia, a type of blood cancer.

FDA said it will allow Lipodox, which is made by Sun Pharma Global FZE (524715.BY) and distributed by Caraco Pharmaceutical Laboratories, to be imported into the U.S. as an alternative to Doxil. The drugs have the same active ingredient. FDA said Doxil is used in multiple treatment regimens, including treatment of ovarian cancer after failure of platinum-based chemotherapy. The drug is also indicated for use in AIDS-related Kaposi's sarcoma and multiple myeloma.

"FDA anticipates that the incoming supply of Lipodox will be able to fully meet patient needs," the agency said in a statement.

Along with approving APP as an additional supplier of preservative-free methotrexate, FDA said Hospira Inc. (HSP) has expedited release of 31,000 vials of new product, which is enough for one month's worth of demand, and is being shipped starting Tuesday.

-By Jennifer Corbett Dooren, Dow Jones Newswires, 202-862-9294; jennifer.corbett@dowjones.com

Hospira (NYSE:HSP)
Gráfico Histórico do Ativo
De Jun 2024 até Jul 2024

Hospira (NYSE:HSP)
Gráfico Histórico do Ativo
De Jul 2023 até Jul 2024