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Mumbai, September 03, 2015:Pharma major Lupin Limited announced today that its subsidiary
Lupin Pharmaceuticals, Inc. (Lupin) has launched its Duloxetine 40 mg Delayed-Release (DR) Capsule, which is
the first and only generic Duloxetine formulation to become available in 40 mg dosage strength. Lupin is excited
to bring this new strength to market, as it adds to the currently-available dosing options for greater flexibility of
Lupin is the only generic manufacturer to offer all Duloxetine dosage strengths – the 20 mg, 30 mg, 60 mg, and
now the newest 40 mg. Lupin’s generic Duloxetine 40 mg DR capsules are therefore the first and only capsule
available for patients in this dosage strength.
Cymbalta® Delayed-Release Capsules 20 mg, 30 mg and 60 mg strengths had annual U.S sales of approximately
USD 1.05 billion (Brand + Generics - IMS MAT June 2015).
Please see the Important Safety Information including a Black Box Warning below. Full prescribing information
is available at http://www.dulox40mgpi.com/pi.pdf.
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS
Duloxetine delayed-release (DR) capsules USP are a prescription medication used to treat or manage:
SELECT IMPORTANT SAFETY INFORMATION
Patients should NOT take Duloxetine if:
SELECT ADDITIONAL WARNINGS & PRECAUTIONS:
Avoid use in patients with chronic liver disease or cirrhosis as hepatic failure, sometimes fatal, has been
reported in patients treated with duloxetine. Duloxetine should be discontinued in patients who develop right,
upper abdominal pain, jaundice or other evidence of clinically significant liver dysfunction. Duloxetine should be
avoided in patients with severe renal impairment, and should not be prescribed to patients with substantial
Cases of orthostatic hypotension, falls and syncope have been reported with duloxetine therapy.
Serotonin Syndrome has been reported with SSRIs and SNRIs, including with duloxetine, both when taken alone,
but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants,
fentanyl, lithium, tramadol, tryptophan, buspirone and St. John’s Wort). Patients should be monitored for the
emergence of Serotonin Syndrome and if symptoms occur, discontinue duloxetine and initiate supportive
Duloxetine may increase the risk of bleeding events. Patients should be cautioned about the risk of bleeding
associated with the concomitant use of duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation.
Severe skin reactions can occur with duloxetine. Duloxetine should be discontinued at the first appearance of
blisters, peeling rash, mucosal erosions or any other sign of hypersensitivity if no other etiology can be
Discontinuation of duloxetine may result in symptoms, including dizziness, headache, nausea, diarrhea,
parasthesia, irritability, vomiting, insomnia, anxiety, hyperhidrosis, and fatigue.
Activation of mania or hypomania has occurred in patients treated with duloxetine.
Angle-closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants.
Duloxetine should be prescribed with care in patients with a history of seizure disorder, and blood pressure
should be monitored prior to initiating treatment and periodically throughout treatment.
Cases of hyponatremia have been reported in patients treated with duloxetine.
Duloxetine may worsen glucose control in diabetes. In diabetic peripheral neuropathic pain patients, small
increases in fasting blood glucose, and HbA have been observed.
The most common adverse reactions include: dry mouth, somnolence, constipation, decreased appetite, and
Duloxetine may cause fetal harm, so talk to your patients if they are or plan to become pregnant. Caution should
be exercised when duloxetine is administered to nursing mothers.
About Lupin Limited
Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of
branded and generic formulations as well as biotechnology products and APIs globally. The Company is a
significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space
and holds global leadership positions in the Anti-TB and Cephalosporin segment.
Lupin is the 5th largest and fastest growing top 5 generics player in the US (5.3% market share by prescriptions,
IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The Company is also amongst the top
10 generic pharmaceutical players in Japan and South Africa (IMS).
For the financial year ended 31st March 2015, Lupin's Consolidated turnover and Profit after Tax were 125,997 million (USD 2.06 billion) and 24,032 million (USD 393 million) respectively. Please visit http://www.lupin.com for more information.
About Aenova Group
The Aenova Group is one of the world’s largest providers of services covering the entire value chain for the
development and production of all the main dosage forms and product groups in the field of medicines and
dietary supplements. As the European business-to-business market leader, the Aenova Group focuses on high
standards of quality, innovative technologies and a clear vision for the future. The group operates overall 29
locations in eleven countries and employs more than 4700 people.
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CIN: L24100MH1983PLC029442 Registered Office: 159, C.S.T. Road, Kalina, Santacruz (East), Mumbai - 400 098.
For further information or queries please contact -
Head – Corporate Communications
Ph: +91-98 20 338 555
Head – M & A and Investor Relations
Ph: +91 98 20 023 511
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