Full Press Release Details
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Please find enclosed a Press Release on
"Dr. Reddy's Laboratories announces the launch of Pyrimethamine Tablets USP, 25 mg, first-wave generic version of Daraprim
in the U.S. Market."
This is for your information.
| /s/ Sandeep Poddar | |
| Sandeep Poddar | |
| Company Secretary |
CC:- New York Stock Exchange Inc.(Stock Code: RDY)
Classification | PUBLIC
| CONTACT | ||
| DR. REDDY'S LABORATORIES LTD. | Investor relationS | Media relationS |
| 8-2-337, Road No. 3, Banjara Hills, Hyderabad - 500034. Telangana, India. | AMIT AGARWAL amita@drreddys.com (Ph: +91-40-49002135) | APARNA TEKURI aparnatekuri@drreddys.com (Ph: +91-40- 49002446) |
Reddy's Laboratories announces the launch of
Pyrimethamine Tablets USP, 25 mg, first-wave generic version
of Daraprim in the U.S. Market
Hyderabad, India and Princeton, NJ, USA. March 20, 2020-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 Pyrimethamine Tablets USP, 25 mg, a therapeutic equivalent and first-wave generic
version of Daraprim (pyrimethamine) Tablets, approved by the U.S. Food and Drug Administration (USFDA). This product
is the only AB-rated generic version Daraprim (pyrimethamine) Tablets approved by the USFDA.
"I am extremely proud of our teams at Dr. Reddy's
and Cerovene whose hard work and efforts, coupled with significant financial investments over the past seven years journey, have
helped bring this important product to market," says, Marc Kikuchi, Chief Executive Officer, North America Generics, Dr.Reddy's
Laboratories. "Our team's relentless pursuit of this difficult-to-procure reference drug and its active pharmaceutical
ingredients-in addition to recent actions from the USFDA (https://www.fda.gov/news-events/press-announcements/fda-approves-first-generic-
daraprim?utm_campaign=FDA%20approves%20first%20generic%20of%20Daraprim%20%28pyrimethamine%29%20tablets&utm_medium=email&utm_source=Eloqua)
-will benefit patients by providing a more affordable alternative to the brand." According to Kikuchi, the company
is offering this product at a substantial discount compared with the current brand price.
"The achievements of the Cerovene team to develop, file
and manufacture Pyrimethamine Tablets is a testament to our dedication and commitment to be able to provide this product to the
patients who need it most. We are pleased to collaborate with Dr. Reddy's as our commercial partner to make this important
drug available to patients in the U.S.," says, Ray DiFalco, Co-Founder and Vice President of Operations for Cerovene. "This
approval represents our continued commitment to develop and provide patients with greater choices and lower-cost alternatives for
prescription pharmaceuticals."
regarding the approval of this product, the USFDA
reiterated its commitment to improve "the efficiency of the generic drug development, review and approval process, as well
as closing loopholes that allow brand-name drug companies to delay the generic competition." The approval and launch of
Dr. Reddy's Pyrimethamine is a testament to the agency's actions, providing generic drug companies the opportunity
to compete fairly in the marketplace.
Pyrimethamine is indicated for the treatment of toxoplasmosis
when used conjointly with a sulfonamide, since synergism exists with this combination.
The Daraprim (pyrimethamine) brand had U.S.
sales of approximately $10 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*.
Dr. Reddy's Pyrimethamine Tablets USP, are available in
25 mg dose in bottle count sizes of 30 and 100.
What Important Information Should I Know About Pyrimethamine
Who Should Not Use Pyrimethamine Tablets USP, 25 mg?
What Should I Tell My Healthcare Provider Before Taking Pyrimethamine
Before taking Pyrimethamine Tablets, tell your doctor if you:
What Are the Adverse Reactions of Pyrimethamine Tablets USP,
Call your doctor or get emergency help right away if you develop:
Anorexia and vomiting may also occur.
What Should I Avoid While Taking Pyrimethamine Tablets USP,
Please refer to the Package Insert for full prescribing information
for Pyrimethamine Tablets USP, 25 mg.
For more information, ask your healthcare provider or pharmacist.
You are encouraged to report negative side effects of prescription drugs. To report suspected side effects, call Dr. Reddy's
Laboratories Medical Information Hotline at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com or contact the
USFDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/safety/medwatch.
Indication and Usage for Pyrimethamine Tablets USP, 25 mg
Please see the full prescribing information.
Daraprim is a trademark owned by or licensed to Vyera Pharmaceuticals,
*IQVIA Retail and Non-Retail MAT January 2020.
About Cerovene: Cerovene, Inc., a privately held
company, is engaged in the research, development and manufacturing of pharmaceuticals. The company's expertise in both solid
and liquid dosage products, extends across a range of drug delivery technologies, including Pulse Release, Delayed and Sustained
Release, Extended Release, Sustained Zero-Order Release, Matrix-Hydrogel Controlled Released, Enteric Coated, Tablet in Capsule
and Coated Capsules. Cerovene developes, files and manufacturers both Branded and Generic pharmaceutical products. For more information
visit www.cerovene.com
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
Disclaimer: This press release may include statements
of future expectations and other forward-looking statements that are based on the management's current views and assumptions
and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially
from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context,
the words "may", "will", "should", "expects", "plans", "intends",
"anticipates", "believes", "estimates", "predicts", "potential", or "continue"
and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from
those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets,
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in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization
, including related integration issues.
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