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Dr. Reddy’s Announces the Launch of Valganciclovir Tablets, USP

2014年12月16日 PM04:57
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HYDERABAD, India

Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Valganciclovir Tablets USP 450 mg, a therapeutic equivalent generic version of VALCYTE® (Valganciclovir) tablets in the US market on December 15, 2014, approved by the United States Food & Drug Administration (USFDA).

The VALCYTE® (Valganciclovir) tablets brand had U.S. sales of approximately $440 Million MAT for the most recent twelve months ending in October 2014 according to IMS Health*.

Dr. Reddy’s Valganciclovir tablets, USP in 450 mg is available in bottle counts of 60.

WARNING: HEMATOLOGIC TOXICITY, CARCINOGENICITY, TERATOGENICITY, AND IMPAIRMENT OF FERTILITY

See full prescribing information for complete boxed warning.

  • Clinical toxicity of valganciclovir, which is metabolized to ganciclovir, includes granulocytopenia, anemia, and thrombocytopenia.
  • In animal studies, ganciclovir was carcinogenic, teratogenic, and caused aspermatogenesis.

Disclaimer

This press release includes forward-looking statements, as defined in the U.S. Private Securities Litigation Reform Act of 1995. We have based these forward-looking statements on our current expectations and projections about future events. Such statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially. Such factors include, but are not limited to, changes in local and global economic conditions, our ability to successfully implement our strategy, the market acceptance of and demand for our products, our growth and expansion, technological change and our exposure to market risks. By their nature, these expectations and projections are only estimates and could be materially different from actual results in the future.

About Dr. Reddy’s

Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) is an integrated global pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses – Pharmaceutical Services and 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. Major therapeutic focus is on gastro-intestinal, cardiovascular, diabetology, oncology, pain management and anti-infective. Major markets include India, USA, Russia-CIS and Europe apart from other select geographies within Emerging Markets. For more information, log on to: www.drreddys.com.

VALCYTE® is a registered trademark of Hoffmann-La Roche Inc.
*IMS National Sales Perspectives: Retail and Non-Retail MAT October 2014

CONTACT

Dr. Reddy’s Laboratories Ltd.
Investors and
Financial Analysts:

Kedar Upadhye, +91-40-66834297
kedaru@drreddys.com
or
Saunak
Savla, +91-40-49002135
saunaks@drreddys.com
or
Ashish
Girotra (USA), +1-609-375-9805
ashishg@drreddys.com
or
Media:
Shilpi
Lathia, +91-40-49002448
shilpil@drreddys.com

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