Tag: Dr. Reddy’s Laboratories Ltd

Health, News

Dr. Reddy’s Laboratories announces the launch of Febuxostat Tablets in the U.S. Market

Jan 12, 2021 by Rekha Nair 0 Comments #Dr. Reddy, #Dr. Reddy’s Laboratories Ltd

Hyderabad, India and Princeton, NJ, USA – Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s”  announced the launch of Febuxostat Tablets, a therapeutic equivalent generic version of Uloric (Febuxostat) Tablets approved by the U.S. Food and Drug Administration (USFDA).

The Uloric brand and generic had U.S. sales of approximately $108 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health*.

Dr. Reddy’s Febuxostat Tablets are available in 40 mg and 80 mg strengths in bottle count sizes of 30 tablets.

Please see the full prescribing information including boxed warning.
https://www.drreddys.com/pi/febuxostat_tablets.pdf

WARNING: CARDIOVASCULAR DEATH

Gout patients with established cardiovascular (CV) disease treated with Febuxostat had a higher rate of CV death compared to those treated with allopurinol in a CV outcomes study [see Warnings and Precautions (5.1)].

Consider the risks and benefits of Febuxostat when deciding to prescribe or continue patients on Febuxostat. Febuxostat should only be used in patients who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable [see Indications and Usage (1)].

Uloric is a trademark of TEIJIN KABUSHIKI KAISHA (TEIJIN LIMITED)
*IQVIA Retail and Non-Retail MAT October 2020.
RDY-0121-323

Health

Dr. Reddy’s and RDIF commence clinical trials for Sputnik V vaccine in India

Dec 1, 2020 by Neel Achary 0 Comments #Dr. Reddy’s Laboratories Ltd, #Hyderabad, #Sputnik V vaccine in India

Hyderabad: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), and Russian Direct Investment Fund (RDIF) announced today that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India.This will be a multicenter and randomized controlled study, which will include safety and immunogenicity study.

The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Further, Dr. Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine.

Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4% efficacy for the vaccine on day 28 after the first dose; vaccine efficacy over 95% 42 days after the first dose. Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose of the vaccine and more than 19,000 – with both the first and second doses of the vaccine.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.”

In September 2020, Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India.

On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the World’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.

Business World

Dr. Reddy’s announces the re-launch of over-the-counter Famotidine Tablets USP, 10 mg and 20 mg, store-brand equivalent of Pepcid AC® in the U.S. Market

Oct 21, 2020 by Gouri Achary 0 Comments #10 mg and 20 mg, #Dr. Reddy’s Laboratories Ltd, #Marc Kikuchi, #OTC Famotidine Tablets USP

Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DR REDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the re-launch of over-the-counter (OTC) Famotidine Tablets USP, 10 mg and 20 mg, the store-brand equivalents of Original Strength and Maximum Strength Pepcid AC®, in the U.S. market, as approved by the U.S. Food and Drug Administration (USFDA).

Dr. Reddy’s OTC Famotidine Tablets USP, 10 mg and 20 mg, are acid reducers that prevent and relieve heartburn associated with acid indigestion and sour stomach brought on by eating or drinking certain food and beverages.

“We are pleased to continue to expand our OTC Antacid portfolio for our customers and consumers,” says Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories. “This launch will help us fulfil an important therapy gap created in Antacids market due to Ranitidine withdrawal.”

The Pepcid AC® brand and generic had U.S. sales of approximately $211 million for the most recent twelve months ending in August 2020 according to IRi*.

Dr. Reddy’s OTC Famotidine Tablets USP, 10 mg and 20 mg, are available in multiple pack sizes to allow consumers a variety of purchasing options.

Pepcid AC® is a registered trademark of Johnson & Johnson

Business World

Dr. Reddy’s Laboratories joins Science Based Targets initiative (SBTi) and sets 2030 GHG emission targets

Oct 6, 2020 by Gouri Achary 0 Comments #(CDP), #(UNGC), #(WRI), #(WWF), #Dr. Reddy’s Laboratories Ltd, #G V Prasad, #Science Based Targets initiative’s (SBTi)

Hyderabad, India, October 5, 2020 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) has joined the Science Based Targets initiative’s (SBTi) business ambition for 1.5°C, becoming the first Indian and the third Asian pharmaceutical company to have set its Science-Based Targets to further minimize environmental impact.

The Company has committed to reducing its Scope 1 and 2 greenhouse gas (GHG) emissions by 55 percent by 2030 from a FY2017-18 base year, which are in line with the latest climate science of limiting global warming to below 1.5°C above pre-industrial levels.

G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said, “Continuous improvement in our environmental performance is a notable aspect of our sustainability journey. We are delighted to join SBTi in taking a science-based approach to set our GHG emission reduction targets and accelerating our efforts to creating a positive impact on our planet.”

As of FY 2019-20, Dr. Reddy’s has reduced its Scope 1 emissions by 8.6% and Scope 2 emissions by 20.7% over the baseline of FY 2017-18. The combined Scope 1 and 2 emissions have been reduced by 13% over the same base year, putting it on a fast track to achieving GHG reduction targets.

Science-Based Targets initiative (SBTi), a joint initiative of Carbon Disclosure Project (CDP), United Nations Global Compact (UNGC), World Resources Institutes (WRI) and World Wide Fund (WWF), provides companies with a clearly defined pathway to future-proof growth by specifying how much and how quickly they need to reduce their greenhouse gas emissions to limit global warming to well-below 2°C above pre-industrial levels. 472 companies have already set their targets as per SBTi. In the Pharmaceutical & Biotech sector globally, 17 companies have successfully set their emission reduction targets affirming their pledge to mitigate climate change impacts.

Business World

Dr. Reddy’s Laboratories announces the launch of Cinacalcet Tablets in the U.S. Market

Oct 3, 2020 by Gouri Achary 0 Comments #Cinacalcet Tablets, #Dr. Reddy’s Laboratories Ltd, #Sensipar (cinacalcet) Tablets

Hyderabad, India and Princeton, NJ, USA. October 2020 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DR REDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Cinacalcet Tablets, a therapeutic equivalent generic version of Sensipar (cinacalcet) Tablets, approved by the U.S. Food and Drug Administration (USFDA).

The Sensipar brand and generic market had U.S. sales of approximately $­­­­­312 million MAT for the most recent twelve months ending in July 2020 according to IQVIA Health*. Dr. Reddy’s Cinacalcet Tablets are available in 30 mg, 60 mg, and 90 mg tablets in a bottle count size of 30.

Please see for full prescribing information. https://www.drreddys.com/pi/cinacalcet-tabs.pdf
Sensipar is a trademark of Amgen Inc. *IQVIA Retail and Non-Retail MAT July 2020 RDY-0920-319

Business World

Dr. Reddy’s announces the launch of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection in the U.S. Market

Sep 26, 2020 by Gouri Achary 0 Comments #Dr. Reddy’s Dexmedetomidine Hydrochloride, #Dr. Reddy’s Laboratories Ltd, #Marc Kikuchi

Hyderabad, India and Princeton, NJ, USA. September 25, 2020 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DR REDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, a therapeutic equivalent generic version of Precedex® (dexmedetomidine hydrochloride) in 0.9% Sodium Chloride Injection, approved by the U.S. Food and Drug Administration (USFDA).

“We are pleased to bring this important generic product to market, making it affordable—and readily available—for patients,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “Our ability to adequately supply Dexmedetomidine is important for patients as it is on the FDA’s Drug Shortage list.”

The Precedex® in 0.9% Sodium Chloride Injection brand and the generic market had U.S. sales of approximately $210 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection is available in 200 mcg/50 mL (4 mcg/mL) and 400 mcg/100 mL (4 mcg/mL) in 50 mL and 100 mL clear glass vials, respectively. The strength is based on the dexmedetomidine base. Containers are intended for single-dose only.

Business World

Dr. Reddy’s Laboratories announces the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe in the U.S. Market

Sep 8, 2020 by Gouri Achary 0 Comments #250 mg/5 mL (50 mg/mL) per Single-dose Syringe, #Dr. Reddy’s Laboratories Ltd, #Fulvestrant Injection, #U.S. Market

Hyderabad, India and Princeton, NJ, USA. September 7, 2020 – Dr Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DR REDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe, a therapeutic equivalent generic version of Faslodex® (fulvestrant) Injection, 250 mg/5 mL (50 mg/mL), approved by the U.S. Food and Drug Administration (USFDA).

The Faslodex® brand and the generic market had U.S. sales of approximately $­­­­­407 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*.

Dr. Reddy’s Fulvestrant Injection, 250 mg/5 mL (50 mg/mL) per Single-dose Syringe is available in a carton containing two 5 mL single-dose prefilled syringes.

Please click here full prescribing information.

Faslodex® is a trademark of the AstraZeneca group of companies.

*IQVIA Retail and Non-Retail MAT June 2020