Full Press Release Details
| Dr. Reddy's Laboratories Ltd. | |
| 8-2-337, Road No. 3, Banjara Hills, | |
| Hyderabad - 500 034, Telangana, | |
| India. | |
| CIN : L85195TG1984PLC004507 | |
| Tel :+91 40 4900 2900 | |
| Fax :+91 40 4900 2999 | |
| Email :mail@drreddys.com | |
| www.drreddys.com |
National Stock Exchange of India Ltd. (Scrip Code: DRREDDY-EQ)
BSE Limited (Scrip Code: 500124)
Please find enclosed a Press Release on "Dr.
Reddy's Laboratories and Senores Pharmaceuticals, Inc. announce the launch Ketorolac Tromethamine Tablets USP, 10 mg in the U.S.
This is for your information.
For Dr. Reddy's Laboratories Limited
| /s/ K Randhir Singh | ||
| K Randhir Singh | ||
| Company Secretary & Compliance Officer |
CC:- New York Stock Exchange Inc.(Stock Code :RDY)
| 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 | USHA IYER ushaiyer@drreddys.com |
Dr. Reddy's Laboratories and Senores Pharmaceuticals,
launch Ketorolac Tromethamine Tablets USP, 10 mg in the U.S. market
Hyderabad, India and Princeton, NJ, USA. May
24, 2022 - Dr. Reddy's Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries
together referred to as "Dr. Reddy's") and Senores Pharmaceuticals, Inc. today announced the launch of Ketorolac
Tromethamine Tablets USP, 10 mg, a therapeutic generic equivalent of the reference listed drug Toradol Tablets, 10 mg in the U.S.
market approved by the U.S. Food and Drug Administration (USFDA).
Ketorolac Tromethamine Tablets USP, 10 mg,
is a nonsteroidal anti-inflammatory drug ("NSAID") indicated for the short-term (up to 5 days in adults) management
of moderately severe acute pain that requires analgesia at the opioid level and only as continuation treatment following intravenous
or intramuscular dosing of ketorolac tromethamine, if necessary.
"We are pleased to partner with Dr. Reddy's
Laboratories for the commercial launch of Ketorolac Tromethamine Tablets in the U.S. market," states Dhananjay Barot, Director,
Senores Pharmaceuticals, Inc.
"Our constant dedication has contributed
to expanding our product portfolio, and today we are a significant and reliable supplier of this product," states Swapnil
Shah, Managing Director, Senores Group.
"We are excited about this launch, and
pleased to partner with Senores to create affordable access to this product and expand our portfolio in the US market," says
Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories.
The Toradol Tablets, 10 mg brand and generic
had U.S. sales of approximately $16.8 million MAT for the most recent twelve months ending in March 2022 according to IQVIA*.
Dr. Reddy's Ketorolac Tromethamine Tablets
USP, 10 mg, are available in bottle count sizes of 100.
Please click here to see the full prescribing
information and approved indication, along with boxed warning for Dr. Reddy's Ketorolac Tromethamine Tablets USP, 10 mg.
Ketorolac tromethamine tablets, a nonsteroidal anti-inflammatory
drug (NSAID), are indicated for the short-term (up to 5 days in adults), management of moderately severe acute pain that requires
analgesia at the opioid level and only as continuation treatment following IV or IM dosing of ketorolac tromethamine, if necessary.
The total combined duration of use of ketorolac tromethamine tablets and ketorolac tromethamine should not exceed 5 days.
Ketorolac tromethamine tablets are not indicated for use in pediatric
patients and they are NOT indicated for minor or chronic painful conditions. Increasing the dose of ketorolac tromethamine tablets
beyond a daily maximum of 40 mg in adults will not provide better efficacy but will increase the risk of developing serious adverse
CARDIOVASCULAR THOMBOTIC EVENTS
Ketorolac tromethamine is CONTRAINDICATED as prophylactic analgesic
before any major surgery.
RISK DURING LABOR AND DELIVERY
CONCOMITANT USE WITH NSAIDs
Important Safety Information: Ketorolac Tromethamine Tablets,
What Important Information Should I Know About Ketorolac Tromethamine
Who Should Not Use Ketorolac Tromethamine Tablets, 10 mg?
What Should I Tell My Healthcare Ketorolac
Tromethamine Tablets, 10 mg?
Before taking Ketorolac Tromethamine
Tablets, tell your doctor if you:
What Are the Possible Side Effects of Ketorolac Tromethamine
| new or worse high blood pressure | - | heart failure | |||
| liver problems including liver failure | - | kidney problems including kidney failure | |||
| life-threatening skin reactions | - | low red blood cells (anemia) | |||
| life-threatening allergic reactions | - | shortness of breath or trouble breathing | |||
| slurred speech | - | chest pain | |||
| swelling of the face or throat | - | weakness in one part or side of your body | |||
| nausea | - | vomit blood | |||
| more tired or weaker than usual | - | blood in your bowel movement or it is black and sticky like tar | |||
| diarrhea | - | unusual weight gain | |||
| itching | - | skin rash or blisters with fever | |||
| your skin or eyes look yellow | - | swelling of the arms, legs, hands and feet | |||
| indigestion or stomach pain | - | flu-like symptoms |
These are not all of the possible side effects
of Ketorolac Tromethamine Tablets, 10 mg. Call your doctor for medical advice about side effects. For more information, ask your
doctor 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 Call Center at 1-888-DRL-DRUG (1-888-375-3784) or via email to medinfo@drreddys.com
or contact the US FDA at 1-800-FDA-1088 (1-800-332-1088) or online at http://www.fda.gov/safety/medwatch. Please refer
to the Ketorolac Tromethamine Tablets, 10 mg Package Inserts for full Prescribing Information and Instructions for Use
Indication and Usage for Ketorolac Tromethamine
About Dr. Reddy's: Dr. Reddy's
Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed
to providing affordable and innovative medicines for healthier lives. 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 Senores Pharmaceuticals, Inc.
Senores Pharmaceuticals, based in Atlanta,
Georgia is one of the fastest-growing pharmaceutical companies in the U.S. market. Currently, the company has more than 15 products
commercially launched or filed with the USFDA. For more information, visit www.senorespharma.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, credit defaults , currency exchange rates, interest rates,
persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing
levels of competition and general competitive factors, (iv) changes 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, and (vi)
the susceptibility of our industry and the markets addressed by our, and our customers', products and services to economic
downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19),
and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including
those listed under the "Risk Factors" and "Forward-Looking Statements" sections of our Annual Report on Form
20-F for the year ended March 31, 2021. The company assumes no obligation to update any information contained herein.