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Please find enclosed a press release on
"Dr. Reddy's Announces Approval of Impoyz (clobetasol propionate) Cream, 0.025% First-Cycle NDA Approval".
This is for your information.
| /s/ Vikas Sabharwal | |
| Vikas Sabharwal | |
| Assistant Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
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| DR. REDDY'S LABORATORIES LTD. 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | Saunak SAVLA saunaks@drreddys.com (Ph: +91-40-49002135) | Calvin Printer calvinprinter@drreddys.com (Ph: +91-40- 49002121) LORI MCCREARY lmccreary@drreddys.com (Ph: +1-412-997-7322) |
Reddy's Announces Approval of Impoyz (clobetasol propionate) Cream,
0.025% First-Cycle NDA Approval
HYDERABAD, India & PRINCETON, NJ & MALVERN, PA December
1, 2017- Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY), through its wholly owned subsidiary
Promius Pharma, LLC, today announced its fifth consecutive, first-cycle NDA approval for the Proprietary Products Group, a substantial
milestone within the pharmaceutical industry.
Impoyz (clobetasol propionate) Cream, 0.025% is a high potency
topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older. The most
common side effect of IMPOYZ Cream includes discoloration of the treated site. Psoriasis is a serious medical condition affecting
approximately 7.5 million people in the United States. Impoyz, formerly referred to as DFD-06, had been recently licensed to Encore
Dermatology Inc. for the commercialization of the product in the United States.
This approval is another example of the deep and broad capabilities
within the Proprietary Products business unit at Dr. Reddy's. The organization has achieved several milestones within drug,
device, and formulation research and development for novel therapies.
"The fifth consecutive first cycle NDA approval represents
Dr. Reddy's long-term commitment to building an organization that delivers innovative medical solutions," said
Anil Namboodiripad, PhD, Senior Vice President, Proprietary Products and President, Promius Pharma. "We are looking
forward to working with our partner, Encore Dermatology, to bring this novel treatment to providers and their patients."
"Encore is excited about adding another great product
to our portfolio and looking forward to the opportunity to commercialize a new product for the treatment of mild to moderate psoriasis
as well as broadening our portfolio outside of atopic dermatitis and acne," said Robert Moccia, CEO, Encore Dermatology,
Important Safety Information
IMPOYZ Cream is indicated for the treatment
of moderate to severe plaque psoriasis in patients 18 years of age or older.
Important: IMPOYZ Cream is for use on the
skin only. Do not get it near or in your eyes, mouth, or vagina.
Before taking IMPOYZ Cream, tell your healthcare provider
about all of your medical conditions, including if you:
Tell your healthcare
provider about all the medicines you take, including over-the-counter medicines, vitamins and herbal supplements. Especially
any other corticosteroid medicines by mouth or use other products on your skin that contain corticosteroids.
What are the possible side effects of IMPOYZ Cream?
The most common side effect of IMPOYZ is discoloration
at the site. This is not the only possible side effect of IMPOYZ Cream. Call your doctor for medical advice about side effects.
Please see IMPOYZ Cream Full Prescribing Information
Impoyz is a trademark of Encore Dermatology Inc.
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
About Encore: Encore Dermatology, Inc is fully-integrated
dermatology company with a mission committed to delivering innovative prescription therapies and medical devices to dermatologists
focusing on customer service and improving the quality-of-life of patients. For more information log onto www.encorederm.com.
Disclaimer: This press release may include statements
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and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially
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the words "may", "will", "should", "expects", "plans", "intends",
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