Navigation Links
TWi Pharmaceuticals Announces Tentative ANDA Approval for Guanfacine Hydrochloride Extended-Release Tablets
Date:5/14/2013

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 Disorder (ADHD) as monotherapy and as adjunctive therapy to stimulant medications.

"We are pleased to receive the tentative approval from U.S. FDA for our Guanfacine Hydrochloride product," said Dr. Calvin C. Chen , President of TWi Pharmaceuticals. "TWi had already reached a settlement agreement with the branded product manufacturer and intends to begin shipping its Guanfacine Hydrochloride product upon receiving the final approval from U.S. FDA."

According to IMS Health, a market research firm, the total annual sales of the branded product, Intuniv®, marketed by Shire US Inc., in U.S. were approximately $448 million in 2012.

About TWi Pharmaceuticals, Inc.

TWi Pharmaceuticals, Inc. is a leading specialty pharmaceutical company based in Taipei, Taiwan, focusing on the development of high barrier generic prescription products ranging from oral controlled release dosage form to novel drug delivery systems including the utilization of nanoparticles, transdermal, and polymeric oral delivery systems. Leveraging its internal research and development capabilities, together with operational flexibility, process development, manufacturing and regulatory expertise, TWi Pharmaceuticals concentrates on products and technologies that present significant barriers to entry or offer Paragraph IV first-to-file or first-to-market opportunities in the United States. For more information of TWi Pharmaceuticals, please visit www.twipharma.com.

Contact:

Michael L. Huang
Head of Investor Relations
Tel: +886-2-2657-3350
Email: michael.huang@twipharma.com


'/>"/>
SOURCE TWi Pharmaceuticals, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. GW Pharmaceuticals to Report Interim 2013 Results and Host Conference Call on 3 June, 2013
2. Jazz Pharmaceuticals Announces Participation In Upcoming Investor Events
3. Anthera Pharmaceuticals Reports 2013 First Quarter Financial Results
4. Arbor Pharmaceuticals Announces FDA Approval of First NDA
5. Optimer Pharmaceuticals Appoints Eric Sirota as Chief Operating Officer
6. Valeant Pharmaceuticals To Webcast 2013 Annual Meeting Of Shareholders
7. Isis Pharmaceuticals to Present at the 2013 UBS Global Healthcare Conference
8. Actinium Pharmaceuticals, Inc. Receives Notice of Patent Allowance for a Key Application
9. Valeant Pharmaceuticals International, Inc. Announces Additional Information Regarding Continuance Proposal
10. Auxilium Pharmaceuticals, Inc. To Present At The Bank Of America Merrill Lynch 2013 Health Care Conference
11. The Zacks Analyst Blog Highlights: Exxon Mobil, Statoil, Chevron, Braskem and Cubist Pharmaceuticals
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/4/2017)... South Korea , Oct. 4, 2017  South ... its next-generation CPR training aide "cprCUBE" on Kickstarter. The ... chest compression during cardiac arrests with better efficiency compared ... It also offers real-time feedback on efficacy of the ... The crowdfunding campaign has a goal to raise $5,000. ...
(Date:10/2/2017)... INDIANAPOLIS , Oct. 2, 2017  Eli Lilly ... its financial results for the third quarter of 2017 ... a conference call on that day with the investment ... performance. The conference call will begin at ... public can access a live webcast of the conference ...
(Date:9/28/2017)... , Sept. 28, 2017 Hill-Rom Holdings, ... 2017 earnings conference call and webcast on Friday, November ... a.m. (EDT) and ending at approximately 8:30 a.m. (CDT) ... discussing the company,s 2017 financial performance and guidance for ... opportunities, initiatives to enhance operational performance, and long-range financial ...
Breaking Medicine Technology:
(Date:10/12/2017)... ANGELES (PRWEB) , ... October 12, 2017 , ... ... Parsa Mohebi Hair Restoration, has recently contributed a medical article to the newly ... on cosmetictown.com. Dr. Mohebi’s article spotlights the hair transplant procedure known as ...
(Date:10/12/2017)... ... October 12, 2017 , ... Leading pediatric oncology experts at Children’s National ... 49th Congress of the International Society of Paediatric Oncology (SIOP) Oct. 12-15. ... for Cancer and Blood Disorders at Children’s National, and Stephen P. Hunger, M.D., ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... named one of Michigan’s 2017 Best and Brightest in Wellness® by Best and ... Wellness® awards program on Friday, Oct. 20 from 7:30 a.m. to 2 p.m. ...
(Date:10/12/2017)... ... October 12, 2017 , ... In ... taxes a year. In some states—like New York, New Jersey, Massachusetts, Texas, Virginia, ... overseas retirement havens have extremely low property-tax rates, which contributes to the relatively ...
(Date:10/12/2017)... ... October 12, 2017 , ... Farm ... California Berkeley, and other leading institutions in announcing the launch of the ... change the way animals are raised for food. , Founding members of the ...
Breaking Medicine News(10 mins):