Dr. Reddy’s Laboratories Announces the Launch of Carmustine for Injection, USP in the U.S. Market

On October 15, 2021 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as "Dr. Reddy’s") reported the launch of Carmustine for Injection, USP, a therapeutic equivalent generic version of BiCNU (carmustine for injection) approved by the U.S. Food and Drug Administration (USFDA) (Press release, Dr Reddy’s, OCT 15, 2021, View Source [SID1234591297]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The BiCNU brand and generic market had U.S. sales of approximately $19.4 million MAT for the most recent twelve months ending in August 2021 according to IQVIA Health*.

Dr. Reddy’s Carmustine for Injection, USP is a lyophilized powder available as a package which includes a single-dose vial containing 100 mg Carmustine USP and a vial containing 3 mL sterile diluent.

Please click here for full prescribing information including boxed warning: View Source

WARNING: MYELOSUPPRESSION and PULMONARY TOXICITY

Myelosuppression

Carmustine causes suppression of marrow function (including thrombocytopenia and leukopenia), which may contribute to bleeding and overwhelming infections. [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Monitor blood counts weekly for at least 6 weeks after each dose. Adjust dosage based on nadir blood counts from the prior dose [see Dosage and Administration (2.1)].

Do not administer a repeat course of Carmustine until blood counts recover.

Pulmonary Toxicity

Carmustine causes dose-related pulmonary toxicity. Patients receiving greater than 1400 mg/m2 cumulative dose are at significantly higher risk than those receiving less. Delayed pulmonary toxicity can occur years after treatment, and can result in death, particularly in patients treated in childhood [see Adverse Reactions (6) and Use in Specific Populations (8.4)].

iCNU is a trademark owned or licensed by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.

*IQVIA Retail and Non-Retail MAT June 2021

RDY-0821-368