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Octapharma USA
Organization
Octapharma USA Inc. is headquartered in Hoboken, NJ. The US sales and marketing office is a fully owned subsidiary of Octapharma AG . For more information about Octapharma USA please call us toll free on 1-866-766-4860 or email us.
Contact Details
Octapharma USA, Inc.
121 River Street, 12th floor Hoboken, NJ, 07030
Tel: 201 604 1130 Fax: 201 604 1131
For all enquiries relating to Drug Safety, or to report Adverse Events please contact our Local Drug Safety Officer:
Tel: 360 990 4318
Fax: 360 876 5266
Legal Notice
Octapharma USA, Inc. invites residents of the United States to access and use this Internet site subject to the terms and conditions detailed here, as well as all applicable laws and regulations. This site and all information containbed in it is intended for access and use by United States residents only.
Product Information
Please click the above link for prescribing information for octagam ® (immune globulin intravenous [human] 5%) and albumin (human)
Ordering
octagam® is available in the US through a small number of carefully selected authorized distributors. For ordering and pricing information please call either our:
Principal Distributors:
ASD 800-746-6273
BioCARE 800-304-3064
FFF 800-843-7477
or
Other Approved Distributors:
HCI 800-456-7283
National Hospital Specialities 800-344-6087
Genesis Bio 800-828-6941
Octapharma USA - Breaking News
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FDA approves 25g / 500ml presentation of octagam®
Octapharma USA Inc. received approval from the FDA on March 26th, for a unique, new vial size of octagam® (immune globulin intravenous [human] 5%).
The 25g vial offers numerous convenience advantages, including reduced storage space requirements, less bottle changes, fewer vial spikes and thus a lower potential for contamination.
The introduction of a 25g vial now means customers have a choice of 5 convenient presentations of octagam®, all of which can be stored at room temperature for 24 months.
Click here for full prescribing information.
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FDA approves Octapharma's albumin solution
Octapharma USA Inc. received approval from the FDA on October 19th, 2006 for albumin (human) 5% & 25% . Both formulations are indicated for the restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated, and use of a colloid is appropriate. Click here for full prescribing information for albumin (human) 5% and albumin (human) 25%
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FDA approves 24 months room temperature storage for octagam®
On 1st September the FDA approved an extension of the shelf-life for octagam® (immune globulin intravenous [human] 5%) from 18 months to 24 months at +2°C to +25°C (36°F to 77°F).
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FDA grants orphan-drug status to uniplas (solvent/detergent [S/D] treated non-blood group specific human coagulation active plasma) for the treatment of thrombotic thrombocytopenic purpura. Click here for more information
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Additional packaging safety innovations for octagam®
Octapharma USA Inc. announced today that it has introduced several new packaging enhancements for octagam® (immune globulin intravenous [human] 5%).
In response to customer feedback, the 5g (100ml) and 10g (200ml) presentations will now be packaged in new plasticized cartons. These offer the advantage of improved strength and durability during transportation and handling.
Additionally, as part of Octapharma’s on-going Quality Assurance program additional measures have been implemented to increase the tamper-proof attributes of the packaging. Click here to read more.
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12-22-07
Voluntary Withdrawal of octagam® (immune globulin intravenous [human] 5%)
Lot #A732B8431 Exp: 08/09
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Octapharma USA Inc. voluntarily withdrew one lot of octagam® following several reports of non life-threating allergic type skin reactions.
If you purchased any of this lot directly from Octapharma, please click here
If you purchased any of this lot from ASD Healthcare, please click here |
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Compliance Program Pursuant to California Law
Pursuant to California Health and Safety Code sections 119400 and 119402, Octapharma USA Inc. has developed and implemented the following Comprehensive Compliance Program.
In compliance with the requirements of California law, Octapharma USA Inc. has made these policies available on this website and, upon request, in a hard-copy version.
California 's laws are part of a panoply of state and federal requirements that govern the conduct of companies such as Octapharma in the marketing, sales and promotions of their products.
Octapharma promotes a culture that supports adherence to high ethical standards and compliance with all applicable legal requirements. The company provides appropriate training to all its US employees to ensure that they conduct business in a complaint, accountable and professional manner. Each employee subject to such training is required to certify that he or she has completed it.
All Octapharma USA Inc. employees must comply with all legal requirements and are expected to report suspected violations of our compliance programs and related policies to their supervisors, the Law and Patents Department, or the Compliance Officer through the Confidential Disclosure policies maintained by the company. Reports may be made anonymously. Octapharma is committed to thorough investigation of all reports it receives and no employee will be subjected to retaliation or any other adverse action for making a report in good faith.
Octapharma USA Inc. declares that it has adopted a compliance program applicable to California medical or health professionals pursuant to California Health and Safety Code sections 119400 and 119402 and that its operations and dealings with California medical or health professionals will comply with its compliance program. Copies of this declaration and the compliance program may be obtained by calling 1-866-766-4860.
Please click here for a copy of Octapharma USA ’s Declaration of Compliance
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