TLC - Taiwan Liposome's application for AmphoTLC approved in India
Taiwan Liposome (TLC) gains 4.3% premarket after in reaction to the announcement that the Central Drugs Standard Control Organization ((CDSCO)) of India has approved the New Drug Application ((NDA)) of Amphotericin B Liposome for Injection 50mg (known as Ampholipad in Taiwan and AmphoTLC in India) for immediate importation per approved usage and indication, to aid in the country’s emergency of acute liposomal amphotericin B shortage. “AmphoTLC is the first and only complex generic drug to have achieved bioequivalence to Gilead’s AmBisome, proving its sameness to the safest form of amphotericin B in the world,” commented George Yeh, President of TLC. "With this approval and prompt delivery of our product, thousands of patients will have the opportunity to receive early treatment with AmphoTLC, reducing the fatality rate brought on by the sudden influx of mucormycosis.” With a soaring number of COVID-19 infections in India, the number of COVID-19 associated mucormycosis ((CAM)) cases has also been on the rise.Mucormycosis is a serious
For further details see:
Taiwan Liposome's application for AmphoTLC approved in India