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Last updated on April 16, 2014 at 5:31 EDT

Latest Sandoz Stories

2014-04-03 12:30:06

LONDON, April 3, 2014 /PRNewswire/ -- Reportbuyer.com just published a new market research report: Injectable Generic and Biosimilar Drugs - Potential Opportunities for Developers 2013 The market for injectable generics has been through a period of consolidation over the last few years as the leading companies have increased their presence through acquisition. The major players include Hospira, Sandoz (Novartis), Hikma Pharmaceuticals, Fresenius Kabi and Teva Pharmaceutical...

2013-10-30 16:26:23

- Novartis files Citizen Petition with FDA, urging uniform approach to use of international nonproprietary names (INN) for all biologic medicines BASEL, Switzerland, Oct. 30, 2013 /PRNewswire/ -- Novartis announced today it has filed a Citizen Petition with the U.S. Food and Drug Administration (FDA), urging the Agency to require that a biosimilar share the same INN as the reference product. Novartis argues that changing the well-established convention that the INN describes the active...

2013-06-19 08:29:17

PARSIPPANY, N.J., June 19, 2013 /PRNewswire/ -- Actavis, Inc. (NYSE: ACT) and Kissei Pharmaceutical Co., LTD today confirmed that they have filed lawsuits against Sandoz Inc., Hetero USA, Inc., Hetero Labs Limited and Hetero Labs Limited, Unit III in the U.S. District Court for the District of Delaware for infringement of U.S. Patent No. 5,387,603 (the '603 patent) covering Rapaflo(®), a treatment for the signs and symptoms of benign prostatic hyperplasia (BPH). Actavis and Kissei's...

2012-07-22 18:21:20

HOLZKIRCHEN, Germany, July 23, 2012 /PRNewswire/ -- Sandoz has completed its USD 1.525 billion acquisition of specialty US dermatology company Fougera Pharmaceuticals on a cash and debt free basis. Fougera had net sales of USD 429 million in 2011 in the US alone and, combined with Sandoz's existing generic dermatology franchise, this positions Sandoz as the new #1 in generic dermatology medicines both globally and in the US. Fougera has strong dermatology development and manufacturing...

2012-05-08 18:20:42

HOLZKIRCHEN, Germany, May 9, 2012 /PRNewswire/ -- Sandoz announced today that Dr. Mark McCamish, Head of Global Biopharmaceutical Development, will present on behalf of the Novartis Group of companies (Novartis) at the May 11 Food and Drug Administration (FDA) public hearing on draft guidances related to the development of biosimilar products. The central message in the Novartis Group testimony will focus on the need for a single science-based regulatory standard that FDA should apply across...

2012-05-02 02:26:44

OXFORD, England, May 2, 2012 /PRNewswire/ -- Oxford BioTherapeutics (OBT) today announces the appointment of Dr Esteban Pombo-Villar as Chief Operations Officer (COO) of the OBT group. In this position he will lead the company's newly created clinical development operations based in Basel, Switzerland. The establishment of a dedicated development operation represents a key milestone in OBT's global expansion as it progresses its most advanced therapeutic antibody and antibody...

2012-04-23 06:27:28

YAOUNDÉ, Cameroon, April 23, 2012 /PRNewswire/ -- - Sandoz products and technical expertise to support local generics manufacturer Cinpharm achieve cGMP certification - Local production facilities to supply high-quality, affordable medicines across Cameroon and neighboring countries - Partnership celebrated by an official ceremony in the presence of the Cameroon Minister of Health and Sandoz officials Sandoz is pleased to announce that its...

2012-03-15 06:00:00

SILVER SPRING, Md, March 15, 2012 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced that it has filed a lawsuit in the U.S. District Court for the District of New Jersey against Sandoz Inc. (Sandoz) for infringement of U.S. Patent Nos. 5,153,222, 6,765,117 and 7,999,007 relating to United Therapeutics' product Remodulin® (treprostinil) injection (Remodulin). The lawsuit is based on an Abbreviated New Drug Application (ANDA) filed by Sandoz with the...

2012-02-06 06:00:00

SILVER SPRING, Md., Feb. 6, 2012 /PRNewswire/ -- United Therapeutics Corporation (NASDAQ: UTHR) today announced receipt of a Paragraph IV Certification Notice Letter on February 3, 2012 from Sandoz Inc. (Sandoz) advising that Sandoz has submitted an Abbreviated New Drug Application (ANDA) to the U.S. Food and Drug Administration (FDA) requesting approval to market a generic version of the 10 mg/mL strength of Remodulin® (treprostinil) injection. In the Notice Letter, Sandoz...

2011-10-25 16:00:00

PISCATAWAY, N.J., Oct. 25, 2011 /PRNewswire/ -- INNOPHARMA LLC announced today FDA approval of its Abbreviated New Drug Application (ANDA) for olanzapine injection (the generic equivalent of Zyprexa® injection). As the developer of this generic injectable drug, INNOPHARMA entered into an agreement with Sandoz Inc., pursuant to which Sandoz will sell, market and distribute the product in the United States. About INNOPHARMA: INNOPHARMA is a sterile product development...