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

Rhea-AI Summary

Dr. Reddy’s Laboratories Ltd. has launched Carmustine for Injection, USP, a therapeutic equivalent generic of BiCNU® approved by the U.S. Food and Drug Administration. The U.S. market for BiCNU® and its generics generated approximately $19.4 million in sales for the twelve months ending August 2021. Carmustine is provided as a lyophilized powder in a single-dose package. However, it carries warnings for myelosuppression and pulmonary toxicity, necessitating careful monitoring of patients' blood counts.

Positive

• Launch of Carmustine for Injection, expanding product portfolio.
• Access to a market worth approximately $19.4 million in the U.S.

Negative

• Warnings for myelosuppression and pulmonary toxicity could impact market acceptance.
• Potential for increased regulatory scrutiny due to safety warnings.

HYDERABAD, India & PRINCETON, N.J.--(BUSINESS WIRE)-- Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced 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).

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: https://www.drreddys.com/media/1019198/carmustine-for-inj-leaflet.pdf

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

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words "may", "will", "should", "expects", "plans", "intends", "anticipates", "believes", "estimates", "predicts", "potential", or "continue" and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form 20-F for the year ended March 31, 2021. The company assumes no obligation to update any information contained herein.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211015005581/en/

INVESTOR RELATIONS

AMIT AGARWAL

AMITA@DRREDDYS.COM

MEDIA RELATIONS

USHA IYER

USHAIYER@DRREDDYS.COM

Source: Dr. Reddy’s Laboratories Ltd.

FAQ

What is the significance of Dr. Reddy's launch of Carmustine for Injection, RDY?

The launch of Carmustine for Injection allows Dr. Reddy's to participate in a market valued at $19.4 million, catering to patients needing this therapeutic equivalent.

What are the safety warnings associated with Carmustine for Injection, RDY?

Carmustine for Injection carries warnings for myelosuppression and pulmonary toxicity, necessitating careful patient monitoring.

What regulatory approval has Carmustine for Injection received, RDY?

Carmustine for Injection has received approval from the U.S. Food and Drug Administration (USFDA).

What does the market look like for Carmustine for Injection, RDY?

The market for Carmustine and BiCNU® generated approximately $19.4 million in U.S. sales for the last twelve months ending August 2021.