Octagam

Type: Product
Name: Octagam
First reported Aug 01 2014 - Updated Aug 01 2014 - 1 reports

Showcase, August 2014

New approvalRecombinant C1-esterase inhibitor (Ruconest—Pharming Group NV, Salix Pharmaceuticals) treats acute attacks in adult and adolescent patients with hereditary angioedema (HAE).HAE is caused by having insufficient amounts of a plasma protein called ... [Published Pharmacist.com - Aug 01 2014]
First reported Jul 27 2014 - Updated Jul 27 2014 - 1 reports

Octapharma USA Updates on FDA Approval of Octagam 10% [Manufacturing Close - Up]

Octapharma USA reported the U.S. Food and Drug Administration (FDA) has approved Octagam 10 percent [Immune Globulin Intravenous (Human) 10 percent (100 mg/mL) Liquid Preparation] for the treatment of adults with chronic Immune Thrombocytopenic Purpura ... [Published Pharmacy Choice - Jul 27 2014]
First reported Jul 22 2014 - Updated Jul 22 2014 - 1 reports

Octapharma receives FDA approval for immune thrombocytopenic purpura drug

Octapharma USA, a manufacturer of human protein products, has received FDA approval for octagam 10%, indicated for the treatment of chronic immune thrombocytopenic purpura, or ITP. Octapharma USA is a subsidiary of Octapharma AG, a global company dedicated ... [Published Individual.com - Jul 22 2014]
First reported Jul 18 2014 - Updated Jul 18 2014 - 1 reports

Octapharma USA Gets FDA OK for Octagam 10%

Octapharma USA reported that the U.S. Food and Drug Administration (FDA) has approved Octagam 10 percent [Immune Globulin Intravenous (Human) 10 percent (100 mg/mL) Liquid Preparation] for the treatment of adults with chronic Immune Thrombocytopenic Purpura ... [Published Individual.com - Jul 18 2014]
First reported Jul 17 2014 - Updated Jul 17 2014 - 1 reports

New 10% IVIG Product Approved

—FDA on Tuesday announced the approval of Octapharma USA Inc.'s 10% i.v. immune globulin (IVIG) solution, Octagam 10%, for the treatment of chronic immune thrombocytopenic purpura in adults.The FDA-approved  labeling (PDF) for the product recommends a ... [Published ASHP - Jul 17 2014]
First reported Jul 16 2014 - Updated Jul 17 2014 - 3 reports

Octapharma gets FDA approval for immune thrombocytopenic purpura therapy Octagam 10%

Octapharma USA has received approval from the US Food and Drug Administration (FDA) for its Octagam 10% to treat adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding ... [Published PBR - News - Jul 17 2014]
First reported Jul 17 2014 - Updated Jul 17 2014 - 1 reports

FDA Approves Octagam 10% for Immune Thrombocytopenic Purpura

Product expected to be available in SeptemberThe FDA has approved Octagam 10% (immune globulin intravenous [human] 10% [100 mg/mL] liquid preparation, Octapharma USA) for the treatment of adults with chronic immune thrombocytopenic purpura (ITP), a platelet ... [Published P&T Community - Jul 17 2014]
First reported Jul 15 2014 - Updated Jul 15 2014 - 5 reports

Octapharma USA, Inc. Announces FDA Approval Of Octagam 10%, Expanding Its Immune Globulin Therapy Portfolio

HOBOKEN, N.J.--(BUSINESS WIRE)--Octapharma USA today announced the U.S. Food and Drug Administration (FDA) has approved Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation] for the treatment of adults with chronic Immune ... [Published BioSpace - Jul 15 2014]

Quotes

...Octapharma milestone, but, more importantly, opens up new treatment options for patients," said Octapharma USA President Flemming Nielsen. "Octagam 10 percent has demonstrated safety and efficacy in a pivotal clinical trial. Octapharma looks forward to providing the product in the U S , further advancing our vision of providing patients with therapies to treat life-threatening conditions."
In the October 2010 issue of the journal Hematology, Robak et al published the article, "Efficacy and safety of a new intravenous immunoglobulin 10% formulation (octagam 10%) in patients with immune thrombocytopenia." The study observed that 81...

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All (14) | News (12) | Reports (0) | Blogs (2) | Audio/Video (0) | Fact Sheets (0) | Press Releases (0)
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Showcase, August 2014 [Published Pharmacist.com - Aug 01 2014]
Octapharma USA Updates on FDA Approval of Octag... [Published Pharmacy Choice - Jul 27 2014]
Octapharma receives FDA approval for immune thr... [Published Individual.com - Jul 22 2014]
Octapharma USA Gets FDA OK for Octagam 10% [Published Individual.com - Jul 18 2014]
New 10% IVIG Product Approved [Published ASHP - Jul 17 2014]
Octapharma gets FDA approval for immune thrombo... [Published PBR - News - Jul 17 2014]
FDA approves Octapharma’s immune thrombocytopen... [Published Pharmaceutical Technology - Jul 17 2014]
FDA Approves Octagam 10% for Immune Thrombocyto... [Published P&T Community - Jul 17 2014]
Hoboken company's platelet disorder drug gains ... [Published New Jersey Online - Jul 16 2014]
Octapharma USA, Inc. Announces FDA Approval Of ... [Published BioSpace - Jul 15 2014]
Octapharma USA Announces FDA Approval of Octaga... [Published FirstWord Pharma - Jul 15 2014]
Octapharma USA Announces FDA Approval of Octaga... [Published Stock Nod - Jul 15 2014]
Octapharma USA Announces FDA Approval of Octaga... [Published CNBC - Jul 15 2014]
Octapharma USA Announces FDA Approval of Octaga... [Published Business Wire Health News - Jul 15 2014]
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Octapharma gets FDA approval for immune thrombo... [Published PBR - News - Jul 17 2014]
Octapharma USA has received approval from the US Food and Drug Administration (FDA) for its Octagam 10% to treat adults with chronic immune thrombocytopenic purpura (ITP), a platelet disorder that can result in easy or excessive bruising and bleeding ...
Octapharma USA Announces FDA Approval of Octaga... [Published Business Wire Health News - Jul 15 2014]
HOBOKEN, N.J.--(BUSINESS WIRE)--Octapharma announces FDA approval of Octagam 10% [Immune Globulin Intravenous (Human) 10% (100 mg/mL) Liquid Preparation] for the treatment of adults with chronic Immune Thrombocytopenic Purpura (ITP) ...
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