Business
Waverley Pharma Announces Tentative ANDA Approval for Pemetrexed in the United States
Waverley Pharma Announces Tentative ANDA Approval for Pemetrexed in the United States ...
About this update from Waverley Pharma, Inc.
[{"type":"text","content":"\n \n \n \n Waverley Pharma Announces Tentative ANDA Approval for Pemetrexed in the United States\n \n \n /* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n \n \n \n \n \n \n Canada NewsWire\n \n \n WINNIPEG, MB, Nov. 12, 2020\n \n \n \n \n WINNIPEG, MB,\n \n Nov. 12, 2020\n \n /CNW/ - Waverley Pharma Inc. (\"Waverley Pharma\" or the \"Company\") (TSXV: WAVE), an emerging Canadian pharmaceutical company, is pleased to announce that the Company has obtained  tentative approval of its Abbreviated New Drug Application (ANDA) for Pemetrexed for Injection, 100 mg and 500 mg (formerly known as \"WAV-101\") in\n \n the United States\n \n (US). The tentative ANDA approval indicates that the technical requirements for approval have been met but approval can not be made effective or marketing begin until the patent on the reference listed drug has expired, which is projected to occur in 2022.\n \n \n \n About Pemetrexed\n \n \n \n Pemetrexed is an injectable chemotherapy product used in the treatment of pleural mesothelioma and non-small cell lung cancer along with other indications. In addition to obtaining tentative ANDA approval in the US, the Company has obtained marketing authorization for this product in numerous European countries and is in the process of filing for market authorization in additional countries across\n \n Europe\n \n .\n \n \n \n About Waverley Pharma\n \n \n \n Waverley Pharma is an emerging pharmaceutical company focused on the development and commercialization of safe, effective, and affordable cancer therapeutics in the European Union,\n \n United Kingdom\n \n and North American market. The Company, through its subsidiary, is currently selling three generic oncology products in the\n \n United Kingdom\n \n , namely capecitabine, temozolomide and erlotinib. In addition, the Company is developing two generic oncology products in\n \n Europe\n \n , namely pemetrexed and bortezomib and additional products in\n \n the United States\n \n . Waverley Pharma is committed to providing patients with affordable prescription medicines that lower healthcare costs and p...