Handa Announces TruPharma’s U.S. Launch Of Its FDA-Approved ANDA for Lamotrigine Extended Release Tablets
Tainan City, Taiwan, June 6, 2017 — Handa Pharmaceuticals, Inc. (Taiwan Exchange: 6620) (together with its wholly owned U.S. subsidiary, Handa Pharmaceuticals, LLC, “Handa”), a specialty pharmaceutical company focusing on the research, development and commercialization of innovative prescription brand and high-barrier generic drug products, announced today that TruPharma, LLC (“TruPharma”) has started to market and distribute Handa’s FDA-approved Abbreviated New Drug Application (“ANDA”) for Lamotrigine Extended Release Tablets, a generic version of GlaxoSmithKline’s LAMICTAL® XR. Handa’s ANDA was approved by FDA on June 17, 2013 and marketing rights reverted to Handa from its previous marketing partner, Wilshire Pharmaceuticals, Inc., on January 5, 2017. TruPharma will exclusively market and distribute the product to all classes of trade in the United States under the TruPharma label. Handa’s Lamotrigine Extended Release Tablets are manufactured in the United States and supplied by Handa to TruPharma.
“Handa is pleased to initiate our first in-house commercial operations in the United States by entering into this exciting new partnership with TruPharma for the marketing and distribution of our Lamotrigine Extended Release Tablets ANDA”, said Bill Liu, Handa’s Chairman and CEO. “We look forward to working with the experienced team at TruPharma to make this important product available to patients.”
Handa’s Lamotrigine Extended Release Tablets are AB-rated, therapeutically equivalent and substitutable for the corresponding strengths of LAMICTAL® XR. Lamotrigine Extended Release Tablets are indicated as adjunctive therapy for primary generalized tonic-clonic seizures and partial-onset seizures with or without secondary generalization in patients aged 13 years and older, and for conversion to monotherapy in patients aged 13 years and older with partial-onset seizures who are receiving treatment with a single antiepileptic drug. According to QuintilesIMS, sales of LAMICTAL® XR and generic equivalents in the United States for the 12 months ended March 31, 2017 were approximately $219 million U.S. dollars.
LAMICTAL® XR is a registered trademark of GlaxoSmithKline.
About Handa Pharmaceuticals, Inc.
Handa is specialty pharmaceutical company focusing on the research, development and commercialization of innovative prescription brand and high-barrier generic drug products. Visit www.handapharma.com.tw for more details.
About TruPharma, LLC
TruPharma is a privately-held sales & marketing company run by seasoned pharmaceutical executives with broad commercial experience. TruPharma partners with developers and manufacturers to bring high-quality prescription products to the U.S. market. Visit www.trupharma.com for more details.
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