Recent News

Recent News

Aug

18
2016

AMERIGEN announces final approval from FDA for generic version of Temodar®

Lyndhurst NJ, USA. August 19, 2016 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Temodar® (temozolomide capsules 5, 20, 100, 140, 180 and 250mg). The product has been launched and is manufactured by Stason Pharmaceuticals, Inc. (“Stason”) in Irvine, CA and is the first approval from the previously announced 2011 collaboration between Amerigen and Stason to develop a portfolio of oral oncology products.


Aug

02
2016

AMERIGEN announces final approval from FDA for generic version of Lysteda®

Lyndhurst NJ, USA. August 2, 2016 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced that the U.S. Food and Drug Administration (FDA) has granted final approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Lysteda® (Tranexamic Acid 650mg instant release tablets). Amerigen had previously filed an ANDA for the product and made a Paragraph IV certification. Ferring Pharmaceuticals Inc. markets Lysteda® in the U.S. to treat cyclic heavy menstrual bleeding. Pursuant to a 2015 agreement with Ferring B.V. and Ferring International Center S.A., Amerigen may launch its generic product under license at an undisclosed future date.

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Jan

12
2016

AMERIGEN and DIPHARMA announce first regulatory submission for Miglustat 100mg Capsules

Lyndhurst NJ, USA, and Chiasso, Switzerland. January 12, 2016 – Amerigen Pharmaceuticals Limited and Dipharma S.A. today announced that a regulatory submission of an Abbreviated New Drug Application for Miglustat 100mg Capsules has been made with the US FDA. This filing is resulting from an exclusive collaboration between Amerigen Pharmaceuticals Limited and Dipharma S.A. to develop and commercialize Miglustat 100mg Capsules, intended to be generic equivalent of  Zavesca® 1, in markets throughout the world.   About Dipharma Dipharma S.A. is a Swiss pharmaceutical company specialized in developing generic high quality medicines for rare diseases. Dipharma S.A. is part of the Dipharma Group, a third generation family company founded in 1949 and  grown to a global presence. The company mission is to improve the quality of life

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Apr

30
2015

AMERIGEN Announces Tentative Approval of Generic Toviaz®

Lyndhurst NJ, USA, April 30, 2015 – Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Toviaz® (Fesoterodine Fumarate Extended-release Tablets, 4mg and 8mg).  Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Toviaz® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Pfizer markets Toviaz® in the U.S. for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. U.S. sales of Toviaz®

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Apr

17
2015

AMERIGEN Announces Tentative Approval of Generic Bystolic®

Lyndhurst NJ, USA, April 17, 2015 – Amerigen Pharmaceuticals Limited today announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval to the Company’s Abbreviated New Drug Application (ANDA) for a generic version of Bystolic (R) (Nebivolol HCl 2.5, 5, 10 and 20mg instant release tablets). Based upon available information, Amerigen believes that it is a first applicant to file an ANDA for Bystolic® containing a Paragraph IV certification, under the provisions of the Hatch-Waxman Act. Forest Laboratories markets Bystolic® in the U.S. for the treatment of hypertension, to lower blood pressure. U.S. sales of Bystolic® were

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Jan

09
2015

Fosun Pharma to invest in Amerigen Pharmaceuticals

Lyndhurst NJ, USA, January 9, 2015 – Amerigen Pharmaceuticals Limited (“Amerigen”) today announced the signing of an agreement with an affiliate of Fosun Pharma (“Fosun”) under which Fosun will invest USD 35 million in newly issued equity in Amerigen. Amerigen intends to use the proceeds primarily to deepen its product pipeline through additional investments in product development and business development. As a result of its investment, Fosun will also be entitled to a seat on Amerigen’s board of directors. Commenting on the deal, John Lowry, Amerigen’s President and CEO, stated “I am delighted to welcome Fosun as an investor in

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Aug

27
2014

Amerigen Pharmaceuticals Limited and the Ningbo Menovo Pharmaceutical Co., Ltd, today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market

Lyndhurst NJ, USA and Ningbo, China, August 27, 2014 – Amerigen Pharmaceuticals Limited (“Amerigen”) and the Ningbo Menovo Pharmaceutical Co., Ltd, (“Menovo”) today announced they had entered into a collaboration agreement regarding the development of generic pharmaceuticals, primarily targeting the United States market. Under the terms of the agreement, Amerigen and Menovo will jointly develop products for Amerigen to commercialize in the United States. Menovo will be responsible for manufacturing API and finished product whereas Amerigen will be responsible for clinical, regulatory and commercial activities in the United States. Amerigen will also provide support and assistance to Menovo in obtaining

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Aug

20
2014

Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic market.

Lyndhurst NJ, USA, August 20th, 2014 – Amerigen Pharmaceuticals Ltd. announces that its Chinese subsidiary, Suzhou Amerigen Pharmaceuticals Co. Ltd., has received Chinese FDA (CFDA) approval and has subsequently launched its generic Mecobalamin 0.5 mg Tablets into the China domestic market. Under the terms of a marketing and distribution agreement with Sinochem Jiangsu Pharmaceutical Co., Ltd., Amerigen is manufacturing the product at its US FDA approved and China CFDA certified oral solid dose facility in Suzhou, China. Sinochem is distributing the product under the Suzhou Amerigen label with exclusive sales rights in the People’s Republic of China. John Lowry, Amerigen’s

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Apr

03
2014

Amerigen has reached an agreement with UPM to commercially manufacture two ANDA products

April 2, 2014. Amerigen Pharmaceuticals, Inc. has reached an agreement with UPM, a division of Gregory Pharmaceutical Holdings, Inc., for UPM to commercially manufacture two ANDA products for a 10 year supply term.  In addition, the agreement allows for UPM to develop and potentially commercially supply several additional ANDA products for Amerigen over the next few years.  UPM acquired the 475,000 square foot Pfizer manufacturing facility in Bristol, Tennessee in July of 2013 and, eventually, all of these products will be made at this new facility. Dr. John M. Gregory, Chairman and CEO of Gregory Pharmaceutical Holdings, Inc., said, “UPM has

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Mar

12
2014

Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration

LYNDHURST, N.J., March 12, 2014 /PRNewswire/ — Amerigen Pharmaceuticals Limited announces that its ANDA for carbidopa 25mg tablets has received final approval from the U.S. Food and Drug Administration. The product is a generic equivalent of Valeant’s Lodosyn® and has been launched under an Amerigen Pharmaceuticals label. John Lowry, Amerigen’s President & CEO commented: “We are very pleased to receive our first ANDA approval. This product was entirely self-developed and manufactured by Amerigen and is the first ANDA approved for which Lodosyn® is the reference listed drug. We look forward to further approvals this year and transitioning our pipeline of

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