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Lupin reçoit l'approbation de la FDA pour le générique de LYRICA(R)


News provided by

Lupin Ltd

Jul 06, 2012, 06:38 ET

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BOMBAY et BALTIMORE, July 6, 2012 /PRNewswire/ --

Pharma major, Lupin Ltd., a annoncé aujourd'hui que sa filiale Lupin Pharmaceuticals Inc. (collectivement, Lupin) a reçu l'approbation finale de la Food and Drug Administration (FDA) américaine pour ses gélules Prégabaline 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg et 300 mg, afin de commercialiser une version générique des gélules LYRICA® (Prégabaline) de C.P. Pharmaceuticals C.V.

Les gélules Prégabaline 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg et 300 mg de Lupin sont l'équivalent générique classé « AB » des gélules LYRICA®, qui sont indiquées pour les douleurs neuropathiques associées à la neuropathie diabétique périphérique, la névralgie post herpétique, le traitement d'appoint des patients adultes souffrant de crises épileptiques partielles et la fibromyalgie.

Les gélules LYRICA® ont enregistré des ventes annuelles aux États-Unis s'élevant à environ 1,8 milliard de dollars pour les douze mois se terminant en mars 2012 (d'après les données relatives aux ventes communiquées par IMS Health).

À propos de Lupin Limited

Lupin, dont le siège social se trouve à Bombay, est une entreprise pharmaceutique transnationale orientée vers l'innovation qui fabrique une vaste gamme de principes actifs et de préparations génériques et de marque. L'entreprise est aujourd'hui particulièrement présente dans les secteurs suivants : cardiovasculaire, diabétologie, asthme, pédiatrie, SNC, gastro-intestinal, anti-infectieux et AINS. Elle occupe en outre une position de leader mondial dans les anti-TB et les céphalosporines.

De par sa taille et le dynamisme de sa croissance, Lupin représente le cinquième fabricant de génériques aux États-Unis (avec une part de marché de 5,3 % des prescriptions, selon IMS Health) ; c'est d'ailleurs la seule entreprise asiatique ayant réussi à atteindre ce statut. Lupin compte aussi parmi les 10 entreprises pharmaceutiques enregistrant la plus forte croissance en Inde, au Japon et en Afrique du Sud (IMS).

Pour l'année financière se terminant en mars 2012, les revenus et les bénéfices consolidés après impôts de Lupin se chiffraient respectivement à 70 829 millions Rs (1,42 milliard USD) et 8 676 millions Rs (190 millions USD). Consultez le site http://www.lupinworld.com pour obtenir plus d'informations.

Lupin Pharmaceuticals, Inc. est la filiale américaine détenue en propriété exclusive de Lupin Limited. Lupin Pharmaceuticals, Inc., dont le siège social se trouve à Baltimore, Maryland, se consacre à la distribution de médicaments génériques de haute qualité à des prix abordables et de préparations de marque qui ont gagné la confiance des patients et des professionnels de santé dans le monde entier. Pour plus d'informations, veuillez vous rendre sur le site http://www.lupinpharmaceuticals.com.

Pour obtenir un complément d'informations ou pour toute demande de renseignements, veuillez contacter :
Shamsher Gorawara
Responsable de la communication d'entreprise
Lupin Limited :
Tél. : +91-98-20-338-555
E-mail : [email protected]

Déclaration de limitation de responsabilité

*LYRICA® est une marque de commerce déposée de C.P. Pharmaceuticals C.V., une filiale détenue en propriété exclusive de Pfizer, Inc.

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