HYDERABAD, India & MISSISSAUGA, Ontario–(BUSINESS WIRE)–Dr. Reddy�s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as Dr. Reddys) today announced that Reddy-Lenalidomide, a generic equivalent to Revlimid® (lenalidomide) capsules, is approved by Health Canada and has been launched in the Canadian market. Reddy-Lenalidomide is one of the first generic medications of its kind to launch in Canada.
Our launch of Reddy-Lenalidomide represents our firm commitment to providing access to affordable medicines for Canadas Multiple Myeloma and Myelodysplastic Syndrome (MDS) patient population, says Vinod Ramachandran, Ph.D., Vice President and General Manager, Dr. Reddys Laboratories Canada. Along with this important launch, we are pleased to introduce our Reddy2Assist Platform, which provides convenient one-stop access to assist prescribers and pharmacists with qualification requirements for patients, as well as patient onboarding and registration via web portal, telephone or fax.
Reddy-Lenalidomide capsules are available in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths, each in blister packs.
Indications & Clinical Use:
Reddy-Lenalidomide is indicated for the treatment of patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Approval for this indication is based on red blood cell transfusion independence response rates. Overall survival benefit has not been demonstrated (see CLINICAL TRIALS, Myelodysplastic Syndromes).
Reddy-Lenalidomide in combination with dexamethasone is indicated for the treatment of multiple myeloma patients who are not eligible for stem cell transplant.
Limitation of Use:
Reddy-Lenalidomide is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials (see WARNINGS AND PRECAUTIONS, Increased Mortality in Patients with CLL).
Contraindications:
Most Serious Warnings and Precautions:
Reddy-Lenalidomide should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents and registered with the Reddy-Lenalidomide RMP controlled distribution program.
Reddy-Lenalidomide is only available under a controlled distribution program called Reddy-Lenalidomide RMP.
Other Relevant Warnings and Precautions:
For More Information:
Consult the Product Monograph at: http://www.drreddys.com/canada/our-products/ for important information on contraindications, warnings, precautions, adverse reactions, interactions, dosing and conditions of clinical use. The Product Monograph is also available through our Medical Information Department.
Revlimid is a trademark owned or licensed by Celgene Corporation.
RDY-0921-CAN
About Dr. Reddys: Dr. Reddys 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. Reddys 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. Reddys 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 managements 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.
Contacts
INVESTOR RELATIONS
AMIT AGARWAL
AMITA@DRREDDYS.COM
MEDIA RELATIONS
USHA IYER
USHAIYER@DRREDDYS.COM
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