Pii to Manufacture FDA-Approved Breast Cancer Drug

September 23, 2019

Pii is now responsible for commercial drug product production of fulvestrant, a breast cancer drug, while Sagent Pharmaceuticals, its abbreviated new drug application holder, will sell, market, and distribute the drug product in the United States.

Pharmaceutics International, Inc. (Pii), a Hunt Valley, MD-based contract development and manufacturing organization, announced that FDA has approved its commercial supply of fulvestrant injection 250mg/5ml drug product for the treatment of breast cancer in post-menopausal patients. Pii is now responsible for commercial drug product production while Sagent Pharmaceuticals, who holds the drug’s abbreviated new drug application, will sell, market, and distribute the drug product in the United States.

“We are pleased to support Sagent Pharmaceuticals in its efforts to supply an affordable treatment option for post-menopausal patients suffering from breast cancer,” said Dr. Kurt Nielsen, Pii's president and CEO, in a Sept. 23, 2019 press release. “Pii’s Pharmaceutics Know-How has once again proven valuable to one of our partners, as they strive to develop and provide approved drug products to patients in need. Fulvestrant [i]njection 250mg/5ml drug product is the [fifth] injectable product approved and produced by Pii, during the past two years.” 

Fulvestrant is the generic version of AstraZeneca’s Faslodex (fulvestrant), approved by FDA in 2002. 

Source: Pii