Mumbai: 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 treatment.

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

• Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants.
• Monitor for worsening and emergence of suicidal thoughts and behaviors.

INDICATIONS:
Duloxetine delayed-release (DR) capsules USP are a prescription medication used to treat or manage:

• Major Depressive Disorder
• Generalized Anxiety Disorder
• Diabetic Peripheral Neuropathic Pain
• Chronic Musculoskeletal Pain

SELECT IMPORTANT SAFETY INFORMATION
Patients should NOT take Duloxetine if:

• They are currently on or have stopped treatment with a monoamine oxidase inhibitor (MAOI) within the last 14 days. Patients should not be treated with an MAOI within 5 days of stopping treatment with duloxetine, as this could cause serious or life-threatening side effects
• They are currently being treated with linezolid or intravenous methylene blue
• They are currently being treated with inhibitors of CYP1A2 or thioridazine.

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 alcohol use.

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 treatment.

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 identified.

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 hyperhidrosis.

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 –

Shamsher Gorawara
Head – Corporate Communications
Ph: +91-98 20 338 555
Email: shamshergorawara@lupin.com

Or

Alpesh Dalal
Head – M & A and Investor Relations
Lupin Limited
Ph: +91 98 20 023 511
Email: alpeshdalal@lupin.com

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