abarelix

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abarelix,

a gonadotropin-releasing hormone antagonist.

indication This drug is used in palliative treatment of prostate cancer.

contraindications Pregnancy, latex allergy, lactation, and known hypersensitivity to this drug prohibit its use. It is also contraindicated for use in children.

adverse effects Adverse effects of this drug include breast enlargement, nipple tenderness, pain on injection, local site reactions, and decreased bone density (with long-term treatment). Life-threatening side effects include anaphylaxis and systemic allergic reaction. Common side effects include headache, dizziness, fatigue, sleep disturbance, nausea, constipation, diarrhea, dysuria, urinary frequency, urinary retention, urinary tract infection, pain (including back pain), and hot flashes.

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Antiandrogen Drugs Plenaxis	Products with REMS in effect (from FDA Federal Register notice) * Generic Brand Abarelix Plenaxis Alosetron Lotronex Ambrisentan Letairis Bosentan Tracleer Clozapine Clozaril, Fazaclo ODT Dofetilide Tikosyn Eculizumab Soliris Fentanyl PCA Ionsys Fentanyl citrate Actiq Isotretinoin Accutane, Amnesteem, Claravis, Sotret Lenalidomide Revlimid Mifepristone Mifeprex Natalizumab Tysabri Small pox (Vaccinia) ACAM2000 Vaccine, Live Sodium oxybate Xyrem * Not all brand names were identified FDA devises initial list of drugs and biologics for REMS by Adverse Event Reporting News The letter cited Salsbury's production of abarelix for failure to sample the active pharmaceutical ingredient (API) "in a representative manner prior to use" and for failure to "appropriately" validate suppliers' analyses of drug components. HUMAN DRUGS by Warning Letter Bulletin Late-State Product Candidates Continue to Advance Amgen's four late-stage development programs, NESP, IL-1ra, abarelix and SD/01 continued to progress during the first quarter, and the company is planning to launch these products in 2001 and 2002. AMGEN REPORTS 9% INCREASE IN FIRST QTR. EARNINGS PER SHARE by Biotech Financial Reports	AATA AAUAAA sequence AAUP AAV Ab Ab amyloid Ab Initio Gene Prediction ab- abacavir abacavir sulfate abacavir sulfate and lamivudine abacterial Abadie's sign Abadie's sign of exophthalmic goiter Abadie's sign of tabes dorsalis abaissement abalienation abalone abamectin abampere abandoned patient Abandonment abandonment of care abapical abaptiston abarelix abarognosis abarthrosis abarticular abarticular gout abarticulation abasia abasia trepidans abasia-astasia abatacept abatement abatic abattoir abaxial Abbe operation Abbé's condenser Abbe-Estlander operation Abbe-Zeiss apparatus ABBI Abbokinase Abbott pump Abbott's method Abbott-Miller tube Abbreviata abbreviated injury scale abbreviated new drug application	Abankin, Pavel Sergeevich Abannation Abano Abano, Pietro d' Abanyala ABAO ABAOC ABAP ABAP ABAP programming language ABAP/4 ABAP4 ABAPC ABAPCLS abapertural ABAPI abapical abapical abapical ABAPSTAS abaptiston Abaq Abar Abar Abar Abar Abar Abarbanel, Isaac ABARC ABARE abarelix ABARI Abarim Abaris Abaris the Hyperborean ABARK abarognosis abarognosis ABARS ABARS ABARSALE abarthrosis abarticular abarticular gout abarticulation abarticulation Abas Abas Abas Abasa Abascal, José Fernando de abase abase abased abased Abasedly abasement abasement Abaser abases abases

Products with REMS in effect (from FDA Federal Register notice) * Generic Brand Abarelix Plenaxis Alosetron Lotronex Ambrisentan Letairis Bosentan Tracleer Clozapine Clozaril, Fazaclo ODT Dofetilide Tikosyn Eculizumab Soliris Fentanyl PCA Ionsys Fentanyl citrate Actiq Isotretinoin Accutane, Amnesteem, Claravis, Sotret Lenalidomide Revlimid Mifepristone Mifeprex Natalizumab Tysabri Small pox (Vaccinia) ACAM2000 Vaccine, Live Sodium oxybate Xyrem * Not all brand names were identified

FDA devises initial list of drugs and biologics for REMS by Adverse Event Reporting News

The letter cited Salsbury's production of abarelix for failure to sample the active pharmaceutical ingredient (API) "in a representative manner prior to use" and for failure to "appropriately" validate suppliers' analyses of drug components.

HUMAN DRUGS by Warning Letter Bulletin

Late-State Product Candidates Continue to Advance Amgen's four late-stage development programs, NESP, IL-1ra, abarelix and SD/01 continued to progress during the first quarter, and the company is planning to launch these products in 2001 and 2002.

AMGEN REPORTS 9% INCREASE IN FIRST QTR. EARNINGS PER SHARE by Biotech Financial Reports

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