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Dr Reddy's Lab launches duloxetine delayed-release capsules

By: Pharma News | Views: 1476 | Date: 07-Jul-2014

Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg, a therapeutic equivalent generic version of CYMBALTA® (Duloxetine¬ Delayed-Release Capsules) in the US market on June 26, 2014. Dr. Reddy’s ANDA is approved by the United States Food & Drug Administration (USFDA).

Dr Reddy's Lab launches duloxetine delayed-release capsules



Dr. Reddy’s Laboratories (NYSE: RDY) announced today that it has launched Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg, a therapeutic equivalent generic version of CYMBALTA® (Duloxetine¬ Delayed-Release Capsules) in the US market on June 26, 2014. Dr. Reddy’s ANDA is approved by the United States Food & Drug Administration (USFDA).

The CYMBALTA® brand and generic had U.S. sales of approximately $5.04 Billion MAT for the most recent twelve months ending in April 2014 according to IMS Health*.

Dr. Reddy’s Duloxetine Delayed-Release Capsules USP 20 mg, 30 mg and 60 mg are available in several bottle counts.

WARNING: SUICIDAL THOUGHTS AND BEHAVIORS

Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older.

In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.Duloxetine is not approved for use in pediatric patients.

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, diabetolog, 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


Drug maker Dr Reddy's Laboratories has launched duloxetine delayed-release capsules USP 20 mg, 30 mg and 60 mg in the US market, the company said on Friday.

According to IMS health, Cymbalata (duloxetine delayed- release capsules) brand and generic had US sales of $5.04 billion for the most recent 12 months ending April 2014, Dr Reddy's said in the statement.

The US FDA in December last year approved the first generic versions of Cymbalta (duloxetine delayed-release capsules), for Aurobindo Pharma Ltd, Dr Reddy's Laboratories Ltd, Lupin Ltd, Sun Pharma Global FZE, Teva Pharmaceuticals USA and Torrent Pharmaceuticals Ltd to market the drug in various strengths.

Cymbalta (duloxetine) is used to treat major depressive disorder, general anxiety disorder and fibromyalgia.

Common adverse reactions reported by people taking Cymbalta include nausea, dry mouth, drowsiness, fatigue, decreased appetite, increased sweating, and dizziness, FDA had said in the website earlier.

Generic prescription drugs approved by the FDA have the same high quality and strength as brand-name drugs.

Generic prescription drug manufacturing and packaging sites must pass the same quality standards as those of brand-name drugs, it had said.

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