ALEMBIC PHARMACEUTICALS LIMITED PRESS RELEASE
19th April, 2017, Vadodara, India
Alembic Pharmaceuticals receives USFDA Tentative Approval for VilazodoneHydrochloride Tablets
Alembic Pharmaceuticals Limited today announced that the company has received tentativeapproval from theUS Food & Drug Administration (USFDA) for itsAbbreviated NewDrug Application (ANDA) for Vilazodone Hydrochloride Tablets, 10mg, 20mg and 40mg. The approved ANDA is therapeuticallyequivalent to the reference listed drug product (RLD) Viibryd® Tablets,10 mg, 20mg and 40mg, of Forest Labs LLC. Vilazodone HydrochlorideTablets are indicatedfor the treatment of Major Depressive Disorder (MOD).Alembic iscurrently in litigationwith Forest Labs LLC inDistrict Court of Delaware and hasstipulated tostay the case in view of theongoing settlement discussions.
Vilazodone HydrochlorideTablets have an estimated market size of US$340 million for twelve monthsending December 2016 according to IMS.
Alembic now has a totalof 54 ANDA approvals (47 final approvals and 7 tentative approvals) from theUSFDA.
About AlembicPharmaceutical s Limited
Alembic Pharmaceuticals Limited, a vertically integrated researchand development pharmaceutical company, has been at the forefront of healthcare since 1907. Headquartered in India,Alembic isa publicly listed company thatmanufactures and markets generic pharmaceutical products all over the world. Alembic's state of theart researchand manufacturing facilities are approved by regulatoryauthorities of many developed countries including theUSFDA. Alembic is one of theleaders inbranded generics in India.Alembic's brands, marketed througha marketingteam of over 5000 are well recognized by doctors and patients.
Information aboutthe company can be found at http://www.alembicpharmaceuticals.com/; (Reuters: ALEM.NS)(Bloomberg: ALPM)(NSE: APLLTD) (BSE: 533573)
For more informationcontact:
Ajay Kumar Desai MitanshuShah ·
Phone: +91 22 - 306 11681Phone: +91265 - 3007630
Email:ajay.desai@alembic.co.in Email:mitanshu.shah@alembic.co.in
ALEM BIC PHARMACEUTICALS LIM ITED
REGO. OFFICE :ALEMBIC ROAD, VADODARA - 390003. INDIA • TEL :+91-0265-2280550 • FAX :+91-0265-2282837
Website :www.alembic-india.com • E-mail:alembic@alembic.co.in
CIN: L24230GJ201OPLC061123
Alembic Pharmaceuticals Limited published this content on 19 April 2017 and is solely responsible for the information contained herein.
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