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Last updated on April 24, 2014 at 1:21 EDT

Latest TWi Pharmaceuticals Inc. Stories

2014-04-23 08:30:49

TAIPEI, April 23, 2014 /PRNewswire/ -- TWi Pharmaceuticals, Inc. today announced that it has entered into a settlement agreement with Endo Pharmaceuticals Inc., Teikoku Seiyaku Co., Ltd. and Teikoku Pharma USA, Inc. to settle all outstanding patent litigation related to TWi's lidocaine topical patch 5% product. An Abbreviated New Drug Application (ANDA) for TWi's product is currently under review at the U.S. Food and Drug Administration (FDA). If approved, TWi's product would be a...

2014-04-07 08:29:00

TAIPEI, April 7, 2014 /PRNewswire/ -- TWi Pharmaceuticals, Inc., today announces the ANDA approval of the generic equivalent to Procardia XL® (Nifedipine) Extended Release Tablets, 30 mg, 60 mg and 90 mg, in the United States. TWi has begun the launch preparation with its US distributor partner and will begin marketing the product as soon as the launch preparation is completed. Procardia XL® 30 mg, 60 mg and 90 mg, Extended Release Tablets marketed by Pfizer Inc and the generic...

2013-07-16 12:27:54

TAIPEI, July 16, 2013 /PRNewswire/ -- TWi Pharmaceuticals, Inc., today announced that it has received an official notification of patent allowance for its metformin controlled release formulation from United States Patent & Trademark Office. The granted patent, US patent number 8,486,453, claims cover the controlled-release composition of TWi's metformin product with reduced food effect. The patent is part of TWi Pharmaceuticals' broad intellectual property portfolio for building...

2013-05-29 04:20:44

TAIPEI, Taiwan, May 29, 2013 /PRNewswire/ -- TWi Pharmaceuticals, Inc., today announced that Teh Seng Pharmaceutical Mfg. Co. (Teh Seng), the manufacturing partner for its generic version of Lidoderm® (5% lidocaine patch) located in Taiwan, has completed the cGMP audit and pre-approval inspection (PAI) by US Food and Drug Administration (FDA) and been granted "acceptable" status under the FDA's regulatory guidelines. "We are pleased to know Teh Seng has received the 'acceptable'...

2013-05-14 08:32:34

TAIPEI, Taiwan, May 14, 2013 /PRNewswire/ -- TWi Pharmaceuticals, Inc. (Taiwan OTC: 4180) today announced that it has received tentative approval for its Abbreviated New Drug Application (ANDA) for Guanfacine Hydrochloride Extended Release Tablets 1mg, 2mg, 3mg and 4mg from the United States Food and Drug Administration (U.S. FDA). Guanfacine Hydrochloride Extended-Release Tablet is a central alpha2A-adrenergic receptor agonist indicated for the treatment of Attention Deficit Hyperactivity...

2012-09-06 06:26:53

PHILADELPHIA, September 6, 2012 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG), announces that its subsidiary, Shire LLC, has settled all pending litigation with Anchen Pharmaceuticals, Inc., and Anchen, Inc.("Anchen") and TWi Pharmaceuticals, Inc. ("TWi") in connection with TWi's Abbreviated New Drug Application ("ANDA") for a generic version of Shire's INTUNIV(R) ( guanfacine hydrochloride) for the treatment of Attention Deficit Hyperactivity Disorder. Anchen is TWi's...

2012-08-06 02:25:26

TAIPEI, Taiwan, Aug. 6, 2012 /PRNewswire-Asia/ -- TWi Pharmaceuticals, Inc., a specialty pharmaceutical company based in Taiwan, today announced its fully owned subsidiary, TWi Biotechnology, Inc. has completed a multinational phase II dose-ranging study of AC-201, an orally available IL-1 Beta modulator, in 259 patients with type II diabetes uncontrolled on up to three oral medications. In the intent-to-treat population, AC-201 showed placebo-corrected reductions in HbA1c of 0.20%,...