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 The leading web portal for pharmacy resources, news, education and careers January 22, 2018
Pharmacy Choice - Pharmaceutical News - China approves Daewoongs clinical trial plans for botulinum toxin Nabota [Arab Finance (Egypt)] - January 22, 2018

Pharmacy News Article

 1/12/18 - China approves Daewoongs clinical trial plans for botulinum toxin Nabota [Arab Finance (Egypt)]

South Koreas Daewoong Pharmaceuticals said Thursday that its clinical trial plans for Nabota, the drugmakers botulinum toxin Type A, has been approved by Chinas drug regulator, paving the way for the drugs future launch in China.

Daewoong said that its clinical trial application for Nabota has been approved by the China Food and Drug Administration. As a result, it will begin phase 3 trials for the drug this year, with aims to commercialize it in China by 2020.

Daewoong Pharmaceuticals China office will carry out the clinical trials, which will focus on proving Nabotas effectiveness in removing wrinkles on the forehead.

Whereas it took rival products an average of 30 months to obtain the CFDAs approval, Nabota was able to secure the approval within just 18 months. Given this, we expect subsequent approval processes to be carried out quickly, said Daewoong Pharmaceuticals Vice Chairman Lee Jong-wook.

In China, the local drug regulator reviews a drugs production and quality control status during the clinical trial application review stage, and does not grant an approval unless such criteria are met. Given this, Daewoong has to clear only the clinical trials before the product can be launched, it said.

Since its debut in Korea in 2014, Nabota has arrived at various markets around the world including Thailand, the Philippines, South America, Mexico and Vietnam. Daewoong has also struck export agreements to sell its BTX treatment in countries in the Middle East, including Saudi Arabia and the United Arab Emirates, as well as India.

In addition, Nabota has been filed for approval by the US Food and Drug Administration and the European Medicines Agency. The US and EU drug regulators are currently reviewing Daewoongs manufacturing facilities to ensure they comply with Good Manufacturing Practice standards, according to the drugmaker.



(c) 2018 2017 Arab Finance Brokerage Company All rights reserved. Provided by SyndiGate Media Inc. (Syndigate.info).

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