Amneal Announces Approval of Carmustine for Injection USP, 100 mg/vial – Preparing for Launch

Amneal Pharmaceuticals announced that it has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg. The Company is planning to commercialize its Carmustine for Injection in November 2018.

“It has been a very productive year for Amneal as our generic pipeline continues to deliver new opportunities,” said Rob Stewart, President and CEO of Amneal. “Year to date, we have received FDA approval on 48 ANDA’s, tentative approval on another 10 ANDA’s and have launched 30 products.”

Stewart continued, “We remain excited about our large and diverse pipeline of over 235 products, which are expected to deliver value to patients and provide significant cash flow to invest in R&D and external growth opportunities.”

According to IQVIA, U.S. market annual sales for the 12 months ended August 2018 for Carmustine for Injection USP, 100 mg/vial is estimated to be approximately $84 million.