|Watson's Generic Avapro Receives FDA Approval; FDA Approves Celgene's ABRAXANE|
|By Staff and Wire Reports|
|Friday, 12 October 2012 18:47|
.3Watson Pharmaceuticals (NYSE: WPI) announced its subsidiary Watson Laboratories, Inc. has received approval from the U.S. FDA on its Abbreviated New Drug Application (ANDA) for Irbesartan Tablets USP, 75 mg, 150 mg and 300 mg, the generic equivalent to Sanofi's Avapro®. Watson intends to begin shipping the product immediately.
Avapro® is indicated for the treatment of hypertension when used alone or in combination with other antihypertensive agents. It is also indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (>300 mg/day) in patients with type 2 diabetes and hypertension.
For the 12 months ending August 31, 2012, Avapro® and its generic equivalents had total U.S. sales of approximately $390 million according to IMS Health data.
Celgene Corporation (NASDAQ: CELG) announced the U.S. FDA has approved ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.
“Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States,” said Dr. Mark A. Socinski, MD, Director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of ABRAXANE phase II and phase III lung cancer trials. “The FDA approval of ABRAXANE is exciting for healthcare professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years.”
Amgen (NASDAQ: AMGN) today announced the appointment of Cynthia M. Patton to senior vice president and chief compliance officer, effective Oct. 22. In this role, Patton will report to Robert A. Bradway, president and chief executive officer, and will be responsible for Amgen's worldwide compliance and business ethics organization.
Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) announcedtoday the initiation of dosing in a Phase 1 multiple dose clinical trial of APD811, a novel oral drug candidate discovered by Arena that targets the prostacyclin (IP) receptor for the treatment of pulmonary arterial hypertension (PAH).
Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the "Company") today announced the pricing of its previously announced public offering of 6.6 million units (the "Offering"), with each unit consisting of one common share and 0.45 of a warrant to purchase one common share, at a purchase price of US$2.50 per unit.
Connectyx Technologies Holdings Group, Inc. (PINKSHEETS: CTYX), www.connectyx.com, a Healthcare Business Process Outsourcing (BPO)company with personal healthcare product offerings, announced today that the company has signed a Letter of Intent (LOI) with SMG Capital. LLC; Family Holiday Club.com, (FHC) as a result of the Business development of BPO healthcare and partner relationship efforts with CallCenterTeam.com.
Genetic Immunity (OTCBB: PWRV), a leader in immunotherapy technology product development, and DKFZ (German Cancer Research Center, Heidelberg, Germany) signed a collaborative agreement to develop a DNA-based vaccine for the treatment of Human Papilloma Virus (HPV) infection that causes cervical cancer and other cancers of the anus, penis, vulva, vagina, and oropharynx.
Unilife Corporation (NASDAQ: UNIS; ASX: UNS) today announced that it will exhibit its portfolio of injectable drug delivery systems at the PDA Universe of Prefilled Syringes and Injection Devices being held in Las Vegas, Nevada between October 15 and 17.