ACIPHEX, RABEPRAZOLE SODIUM, patent exp 8 th Nov 2013

New Drug Approvals

AS SODIUM SALT

Bottle of rabeprazole 20 mg tablets

ACIPHEX, RABEPRAZOLE SODIUM

Drug Patent Expiration and Exclusivity

US 5045552 – Uspto – United States Patent and Trademark Office

Active Ingredient Form Dosage Drug Type Application Product
RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE; ORAL 10MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** DISCN 020973 001
RABEPRAZOLE SODIUM TABLET, DELAYED RELEASE; ORAL 20MG RX 020973 002

EISAI INC’s ACIPHEX.

Patent Expiration
US 5045552*PED 2013-11-8
US 5045552 Pyridine derivatives having anti-ulcerative activity
Pyridine derivatives useful for preventing or treating peptic ulcers, pharmaceutical preparations and methods of treating peptic ulcers are described.
2013-5-8(expired)

Exclusivity

Exclusivity is marketing rights granted by the FDA to the EISAI INC.

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Health Canada approves Levemir® FlexTouch® prefilled insulin pen for the treatment of type 1 and type 2 diabetes

New Drug Approvals

MISSISSAUGA, ON, Oct. 18, 2013 /CNW/ – Novo Nordisk today announced that Health Canada has approved Levemir® FlexTouch®, a disposable prefilled insulin pen containing Levemir® (insulin detemir). Levemir® FlexTouch® has been designed to improve ease of use for insulin administration and to help decrease barriers to good treatment adherence for Canadians living with type 1 and type 2 diabetes mellitus (diabetes).

The approval was also announced at the 2013 Vascular Conference in Montreal, Quebec.

Health Canada approves Levemir® FlexTouch® prefilled insulin pen for the treatment of type 1 and type 2 diabetes

http://www.pharmalive.com/health-canada-approves-levemir-flextouch

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Epratuzumab

New Drug Approvals

Epratuzumab

Epratuzumab is a humanised anti-CD22 monoclonal antibody under investigation (clinical development phase III) for its efficacy in SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function.

Expected indication Systemic lupus erythematosus
R&D stage Phase 3 ongoing (started in December 2010)
Next milestone Phase 3 results (H1 2014)
Quick facts

Epratuzumab is a humanized monoclonal antibody. Potential uses may be found inoncology and in treatment of inflammatory autoimmune disorders, such as lupus (SLE).[1][2] The manufacturers in August 2009 announced success in early trials against SLE.[3]

Epratuzumab binds to the glycoprotein CD22 of mature and malignant B-cells.

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Epratuzumab

New Drug Approvals

Epratuzumab

Epratuzumab is a humanised anti-CD22 monoclonal antibody under investigation (clinical development phase III) for its efficacy in SLE. CD22 is a B cell specific surface protein that is considered to be involved in B cell function.

Expected indication Systemic lupus erythematosus
R&D stage Phase 3 ongoing (started in December 2010)
Next milestone Phase 3 results (H1 2014)
Quick facts

Epratuzumab is a humanized monoclonal antibody. Potential uses may be found inoncology and in treatment of inflammatory autoimmune disorders, such as lupus (SLE).[1][2] The manufacturers in August 2009 announced success in early trials against SLE.[3]

Epratuzumab binds to the glycoprotein CD22 of mature and malignant B-cells.

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GSK and Genmab seek alternative approval for leukaemia drug Arzerra

New Drug Approvals

Arzerra

GlaxoSmithKline and Genmab A/S have announced the submission of leukaemia drug Arzerra to the European Medicines Agency (EMA) for a variation in marketing authorisation.

The companies are seeking authorisation for the drug to be used in combination with an alkylator-based therapy for treatment of Chronic Lymphocytic Leukemia (CLL) patients who have not received prior treatment and are inappropriate for fludarabine-based therapy.

READ ALL AT

http://www.pharmaceutical-technology.com/news/newsgsk-and-genmab-seek-alternative-approval-leukaemia-drug-arzerra?WT.mc_id=DN_News

Ofatumumab(trade name Arzerra, also known as HuMax-CD20) is a humanmonoclonal antibody (for the CD20 protein) which appears to inhibit early-stage B lymphocyte activation. It is FDA approved for treating chronic lymphocytic leukemia that is refractory to fludarabine and alemtuzumab (Campath) and has also shown potential in treating Follicular non-Hodgkin’s lymphoma, Diffuse large B cell lymphoma, rheumatoid arthritis and relapsing remitting multiple sclerosis. Ofatumumab has also received conditional approval in Europe for the treatment of refractory chronic lymphocytic leukemia…

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