Nitrosoureas

STI Pharma Announces US Launch of Generic BICNU® for Injection

Retrieved on: 
Thursday, November 21, 2019
Health, Articles, Pharmaceutical industry, Carmustine, Nitrosoureas, Organochlorides, Ureas, Generic drug, Abbreviated New Drug Application, STI, Food and Drug Administration, New Drug Application

NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.

Key Points: 
  • NEWTOWN, Pa., Nov. 21, 2019 /PRNewswire/ -- STI Pharma, LLC today announced the US launch of Carmustine for Injection, USP: 1 Kit (100mg per Vial & Diluent), a generic version of AVET's (formerly Heritage) BiCNU.
  • STI received the final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product.
  • "The launch of Carmustine Injection is an important milestone for STI, representing our first oncology injectable approval," said STI President Frank Mullery.
  • STI Pharma, located in Newtown, PA, was founded in 2008 by a team of industry veterans.

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

Retrieved on: 
Friday, October 19, 2018
Health, Chemistry, Carmustine, Nitrosoureas, Organic chemistry, Ureas, Amneal Pharmaceuticals, Food and Drug Administration

BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg.

Key Points: 
  • BRIDGEWATER, N.J., Oct. 19, 2018 /PRNewswire/ --Amneal Pharmaceuticals, Inc. (NYSE: AMRX), today announced that it has received FDA approval for a generic version of BiCNU (carmustine) for injection, 100 mg.
  • "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."
  • 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.