Category Archives: New drugs

Temsirolimus (Torisel): kinase inhibitor for the treatment of advanced renal cell carcinoma. Australian Prescriber review

From Australian Prescriber: Temsirolimus Torisel (Wyeth) vials containing 25 mg/mL concentrate Approved indication: advanced renal cell carcinoma Australian Medicines Handbook section 14.2.3 About 30% of patients with renal cell carcinoma have advanced or metastatic disease at the time of diagnosis. Chemotherapy is generally ineffective and nephrectomy is the mainstay of treatment for disease confined to…Continue Reading

Paricalcitol (Zemplar): a vitamin D analogue for the treatment of secondary hyperparathyroidism. Australian Prescriber review

From Australian Prescriber: Paricalcitol Zemplar (Abbott) 1 microgram, 2 microgram and 4 microgram capsules 5 microgram/mL in 1 mL and 2 mL ampoules Approved indication: secondary hyperparathyroidism Australian Medicines Handbook section 10.3.2 In chronic renal failure there is reduced production of calcitriol, the active form of vitamin D. This affects calcium homeostasis and leads to…Continue Reading

Anti-thymocyte globulin (Thymoglobuline) for renal transplant rejection and aplastic anaemia. Australian Prescriber review

From Australian Prescriber: Anti-thymocyte globulin Thymoglobuline (Genzyme) vials containing 25 mg freeze-dried powder Approved indication: renal transplant rejection and aplastic anaemia Australian Medicines Handbook section 14.5.3 Anti-thymocyte globulin is indicated for the prophylaxis of renal graft rejection as well as the treatment of steroid-resistant renal transplant rejection. Kidney transplantation is the treatment of choice for…Continue Reading

FDA approves gadofosveset trisodium (Vasovist) as first contrast agent for magnetic resonance angiography (MRA)

FDA press release about the approval of Vasovist (gadofosveset trisodium), the first contrast agent for magnetic resonance angiography. Dated December 24, 2008. FDA Approves First Imaging Agent to Enhance Scans of Blood Flow Helps detect possible blood vessel problems The U.S. Food and Drug Administration today approved Vasovist Injection (gadofosveset trisodium), the first contrast imaging agent for…Continue Reading

Romiplostim (Nplate) for idiopathic thrombocytopenic purpura. Review by Australian Prescriber

Australian Prescriber review of romiplostim, first bone marrow stimulator, for the treatment of idiopathic thrombocytopenic purpura: Romiplostim Nplate (Amgen) vials containing 375 microgram and 625 microgram for reconstitution Approved indication: idiopathic thrombocytopenic purpura Australian Medicines Handbook Appendix A One of the causes of thrombocytopenia is idiopathic thrombocytopenic purpura. As the platelets are destroyed by antiplatelet…Continue Reading

Maraviroc (Selzentry, Celsentri), a CCR5 inhibitor for the treatment of HIV infection. An Australian Prescriber review

A review from the Australian Prescriber website of a new drug for the treatment of HIV infection: Maraviroc Celsentri (Pfizer) 150 mg and 300 mg film-coated tablets Approved indication: HIV infection Australian Medicines Handbook section 5.4 Highly active antiretroviral therapy has improved survival for patients infected by HIV, but long-term toxicity and the development of…Continue Reading

EMEA press release: CHMP adopted positive opinion about mifamurtide (Mepact) for the treatment of osteosarcoma

EMEA press release informing the CHMP positive opinion about mifamurtide (Mepact), for the treatment of high grade resectable non metastatic osteosarcoma. COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for MEPACT International Nonproprietary Name (INN): mifamurtide On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive…Continue Reading

EMEA press release: CHMP positive opinion about degarelix (Firmagon) for prostate cancer

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for FIRMAGON International Nonproprietary Name (INN): degarelix (as acetate) On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product Firmagon, 80 mg and 120 mg, powder and…Continue Reading

FDA approves plerixafor (Mozobil) for use in multiple myeloma and non Hodgkin’s lymphomas

From the FDA’s newsroom: FDA Approves Drug that Boosts Stem Cell Yield for Bone Marrow Transplants The U.S. Food and Drug Administration today approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used…Continue Reading

CHMP positive opinion for lasofoxifene (Fablyn), a new SERM

Press release about the positive opinion of the CHMP for Fablyn (lasofoxifene): COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE  SUMMARY OF POSITIVE OPINION for FABLYN International Nonproprietary Name (INN): lasofoxifene On 18 December 2008  the Committee for Medicinal Products  for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the…Continue Reading

EMEA press release: CHMP adopted a positive opinion about japanese encephalitis vaccine (Ixiaro)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE SUMMARY OF POSITIVE OPINION for IXIARO Common Name: Japanese Encephalitis vaccine, inactivated, adsorbed On 18 December 2008 the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending to grant a marketing authorisation for the medicinal product IXIARO, containing a target total protein amount of…Continue Reading

EMEA press release: CHMP adopted a positive opinion for pandemic influenza vaccine H5N1 (Celvapan)

COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE  SUMMARY OF POSITIVE OPINION for CELVAPAN Common Name: Pandemic Influenza Vaccine (H5N1 whole virion, Vero cell derived, inactivated) On 18 December 2008  the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion,  recommending the granting of a marketing authorisation for the medicinal product Celvapan, 7.5…Continue Reading

Toviaz (fesoterodine fumarate): new drug to treat overactive bladder

FDA press release about the approval of Toviaz (fesoterodine fumarate): The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage…

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