Dr. Reddy’s Laboratories Announces First-to-market Launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) Single-dose Vial in the U.S. Market

July 3, 2019 Off By BusinessWire

HYDERABAD, India & PRINCETON, N.J.–(BUSINESS WIRE)–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) Single-dose Vial, a therapeutic equivalent generic version of Hemabate® injection, 250 mcg/mL, approved by the U.S. Food and Drug Administration (USFDA).

“We are pleased to be first-to-market with this product that has been designated as a Competitive Generic Therapy (CGT) by the FDA,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “With a CGT designation, we have 180-day CGT exclusivity to market this product.”

The Hemabate® injection, 250 mcg/mL brand had U.S. sales of approximately $55 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health*.

Dr. Reddy’s Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) contains carboprost tromethamine equivalent to 250 mcg of carboprost.

WARNINGS:

Carboprost Tromethamine Injection sterile solution (carboprost tromethamine) like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. Carboprost Tromethamine Injection should be used by medically trained personnel in a hospital which can provide immediate intensive care and acute surgical facilities.

Hemabate is a trademark of Pfizer

*IQIA Retail and Non-Retail MAT May 2019

RDY-0619-254

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) 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

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