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 U.S. 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.
BOXED WARNING
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 events.
GASTROINTESTINAL RISK
- Ketorolac tromethamine, including ketorolac tromethamine
tablets can cause peptic ulcers, gastrointestinal bleeding and/or
perforation of the stomach or intestines, which can be fatal. These
events can occur at any time during use and without warning
symptoms. Therefore, ketorolac tromethamine is CONTRAINDICATED in
patients with active peptic ulcer disease, in patients with recent
gastrointestinal bleeding or perforation, and in patients with a
history of peptic ulcer disease or gastrointestinal bleeding.
Elderly patients are at greater risk for serious gastrointestinal
events (see WARNINGS).
CARDIOVASCULAR THOMBOTIC EVENTS
- Nonsteroidal anti-inflammatory drugs (NSAIDs) cause an
increased risk of serious cardiovascular thrombotic events,
including myocardial infarction and stroke, which can be fatal.
This risk may occur early in treatment and may increase with
duration of use (see WARNINGS and PRECAUTIONS).
- Ketorolac tromethamine tablets are contraindicated in the
setting of coronary artery bypass graft (CABG) surgery (see
CONTRAINDICATIONS and WARNINGS).
RENAL RISK
- Ketorolac tromethamine is CONTRAINDICATED in patients with
advanced renal impairment and in patients at risk for renal failure
due to volume depletion (see WARNINGS).
RISK OF BLEEDING
- Ketorolac tromethamine inhibits platelet function and is,
therefore, CONTRAINDICATED in patients with suspected or confirmed
cerebrovascular bleeding, patients with hemorrhagic diathesis,
incomplete hemostasis and those at high risk of bleeding (see
WARNINGS and PRECAUTIONS).
Ketorolac tromethamine is
CONTRAINDICATED as prophylactic analgesic before any major
surgery.
RISK DURING LABOR AND DELIVERY
- The use of ketorolac tromethamine in labor and delivery is
contraindicated because it may adversely affect fetal circulation
and inhibituterine contractions.
CONCOMITANT USE WITH NSAIDs
- Ketorolac tromethamine is CONTRAINDICATED in patients currently
receiving aspirin or NSAIDs because of the cumulative risk of
inducing serious NSAID-related side effects.
SPECIAL POPULATIONS
- Dosage should be adjusted for patients 65 years or older, for
patients under 50 kg (110 lbs) of body weight (see DOSAGE AND
ADMINISTRATION) and for patients with moderately elevated serum
creatinine (see WARNINGS).
Important Safety Information: Ketorolac Tromethamine Tablets,
10 mg
What Important Information Should I Know About Ketorolac
Tromethamine Tablets, 10 mg?
- GASTROINTESTINAL RISK: Ketorolac tromethamine, including
ketorolac tromethamine tablets can cause peptic ulcers,
gastrointestinal bleeding and/or perforation of the stomach or
intestines, which can be fatal. These events can occur at any time
during use and without warning symptoms. Therefore, ketorolac
tromethamine is CONTRAINDICATED in patients with active peptic
ulcer disease, in patients with recent gastrointestinal bleeding or
perforation, and in patients with a history of peptic ulcer disease
or gastrointestinal bleeding. Elderly patients are at greater risk
for serious gastrointestinal events.
- CARDIOVASCULAR THOMBOTIC EVENTS: Nonsteroidal
anti-inflammatory drugs (NSAIDs) cause an increased risk of serious
cardiovascular thrombotic events, including myocardial infarction
and stroke, which can be fatal. This risk may occur early in
treatment and may increase with duration of use. Ketorolac
tromethamine tablets are contraindicated in the setting of coronary
artery bypass graft (CABG) surgery.
- RENAL RISK: Ketorolac tromethamine is CONTRAINDICATED in
patients with advanced renal impairment and in patients at risk for
renal failure due to volume depletion.
- RISK OF BLEEDING: Ketorolac tromethamine inhibits
platelet function and is, therefore, CONTRAINDICATED in patients
with suspected or confirmed cerebrovascular bleeding, patients with
hemorrhagic diathesis, incomplete hemostasis and those at high risk
of bleeding. Ketorolac tromethamine is CONTRAINDICATED as
prophylactic analgesic before any major surgery.
- RISK DURING LABOR AND DELIVERY: The use of ketorolac
tromethamine in labor and delivery is contraindicated because it
may adversely affect fetal circulation and inhibit uterine
contractions.
- CONCOMITANT USE WITH NSAIDs: Ketorolac tromethamine is
CONTRAINDICATED in patients currently receiving aspirin or NSAIDs
because of the cumulative risk of inducing serious NSAID-related
side effects.
- SPECIAL POPULATIONS: Dosage should be adjusted for
patients 65 years or older, for patients under 50 kg (110 lbs) of
body weight.
Who Should Not Use Ketorolac Tromethamine Tablets, 10
mg?
- Ketorolac tromethamine is contraindicated in patients with
previously demonstrated hypersensitivity to ketorolac
tromethamine
- Ketorolac tromethamine is contraindicated in patients with
active peptic ulcer disease, in patients with recent
gastrointestinal bleeding or perforation
- Ketorolac tromethamine should not be given to patients who have
experienced asthma, urticaria, or allergic-type reactions after
taking aspirin or other NSAIDs. Severe, rarely fatal,
anaphylactic-like reactions to NSAIDs have been reported in such
patients.
- right before or after heart bypass surgery
- The concomitant use of ketorolac tromethamine and probenecid is
contraindicated
- The concomitant use of ketorolac tromethamine and
pentoxifylline is contraindicated
What Should I Tell My Healthcare Ketorolac Tromethamine
Tablets, 10 mg?
Before taking Ketorolac Tromethamine Tablets, tell your doctor
if you:
- have liver or kidney problems
- have high blood pressure
- have asthma
- are pregnant or plan to become pregnant. Taking NSAIDs at about
20 weeks of pregnancy or later may harm your unborn baby. If you
need to take NSAIDs for more than 2 days when you are between 20
and 30 weeks of pregnancy, your healthcare provider may need to
monitor the amount of fluid in your womb around your baby. You
should not take NSAIDs after about 30 weeks of pregnancy.
- are breastfeeding or plan to breast feed.
What Are the Possible Side Effects of Ketorolac Tromethamine
Tablets, 10 mg?
- new or worse high blood pressure
- 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
- swelling of the face or throat
- weakness in one part or side of your body
- more tired or weaker than usual
- blood in your bowel movement or it is black and sticky like
tar
- skin rash or blisters with fever
- your skin or eyes look yellow
- swelling of the arms, legs, hands and feet
- indigestion or stomach pain
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 Tablets, 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.
*IQVIA Retail and Non-Retail MAT March 2022.
RDY-0522-410
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.
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INVESTOR RELATIONS AMIT AGARWAL AMITA@DRREDDYS.COM
MEDIA RELATIONS USHA IYER USHAIYER@DRREDDYS.COM
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