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Drug News
Five-day dosing regimen for Dacogen approved for myelodysplastic syndromes (MDS)
March 12, 2010
The FDA has approved a five-day dosing regimen for Dacogen (decitabine for injection, from Eisai) to treat patients with myelodysplastic syndromes (MDS).
Trelstar 22.5mg approved for palliative treatment of prostate cancer
March 11, 2010
The FDA has approved Trelstar 22.5mg (triptorelin pamoate for injectable suspension, from Watson) for the palliative treatment of advanced prostate cancer.
Botox approved for upper limb spasticity
March 10, 2010
The FDA has approved Botox (onabotulinumtoxin A, from Allergan) for the treatment of spasticity in the flexor muscles of the elbow, wrist, and fingers in adults.
Pediaderm HC Complete Kit available for atopic dermatitis
March 09, 2010
Arbor Pharmaceuticals announced the launch of Pediaderm HC Complete Kit which contains Pediaderm HC (hydrocortisone lotion 2%) and nonsteroidal Pediaderm Protective Emollient with Triple Synergy Technology.
Generic timolol maleate ophthalmic gel forming solution available
March 09, 2010
Aton Pharma announced the availability of an authorized generic version of its Timoptic-XE (timolol maleate ophthalmic gel forming solution).
Xiaflex available for Dupuytren's contracture
March 08, 2010
BioSpecifics Technologies and Auxilium Pharmaceuticals announced the availability of Xiaflex (collagenase clostridium histolyticum) for the treatment of adult Dupuytren's contracture patients with a palpable cord.
Hizentra approved for primary immunodeficiency
March 05, 2010
The FDA has approved CSL Behring's Hizentra (immune globulin [human] 20% liquid for subcutaneous injection) for the once weekly treatment of primary immunodeficiency.
Kapidex to be marketed under new trade name Dexilant
March 04, 2010
Takeda Pharmaceuticals announced that Kapidex (dexlansoprazole delayed-release capsules) will now be marketed under a new product trade name, Dexilant, due to reports of dispensing errors.
Norditropin FlexPro pen approved for growth hormone treatment
March 03, 2010
The FDA has approved Norditropin FlexPro (somatropin [rDNA origin] injection, from Novo Nordisk), a pre-filled injection pen, for patients with growth hormone disorders.
Generic tamsulosin available for benign prostatic hyperplasia (BPH)
March 03, 2010
The FDA has approved a generic version of Flomax (tamsulosin HCl capsules, from Boehringer Ingelheim) for the treatment of benign prostatic hyperplasia (BPH).
more »
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New Drug Products
VICTOZA
3/11/2010
Active Ingredient(s):
Liraglutide [rDNA origin] 6mg/mL; soln for SC inj.
ISTODAX
3/4/2010
Active Ingredient(s):
Romidepsin 10mg/vial; pwd for IV infusion after reconstitution and dilution; contains povidone.
ARZERRA
2/25/2010
Active Ingredient(s):
Ofatumumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
FANAPT
2/19/2010
Active Ingredient(s):
Iloperidone 1mg, 2mg, 4mg, 6mg, 8mg, 10mg, 12mg; tabs.
ACTEMRA
2/12/2010
Active Ingredient(s):
Tocilizumab 20mg/mL; soln for IV infusion after dilution; preservative-free.
more »
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FDA reviews atypical subtrochanteric femur fractures risk with oral bisphosphonates
Pediaderm HC Complete Kit available for atopic dermatitis
Xiaflex available for Dupuytren's contracture
Botox approved for upper limb spasticity
Trelstar 22.5mg approved for palliative treatment of prostate cancer
New Product: SAPHRIS
®
(asenapine) Sublingual Tablets
Generic timolol maleate ophthalmic gel forming solution available
FDA warns of intravascular hemolysis risk with WinRho SDF
Five-day dosing regimen for Dacogen approved for myelodysplastic syndromes (MDS)
FDA accepts NDA for lurasidone, a treatment for schizophrenia
Recommended Adult Immunization Schedule
FDA reviews atypical subtrochanteric femur fractures risk with oral bisphosphonates
Prevnar 13 pneumococcal disease vaccine approved
Hizentra approved for primary immunodeficiency
Kapidex to be marketed under new trade name Dexilant
FDA grants priority review to Tasigna for newly diagnosed chronic myeloid leukemia
FDA accepts NDA for JZP-6, a treatment for fibromyalgia
Rituxan approved for chronic lymphocytic leukemia
Victoza available for type 2 diabetes
Generic tamsulosin available for benign prostatic hyperplasia (BPH)
Five-day dosing regimen for Dacogen approved for myelodysplastic syndromes (MDS)
FDA reviews atypical subtrochanteric femur fractures risk with oral bisphosphonates
Trelstar 22.5mg approved for palliative treatment of prostate cancer
FDA accepts NDA for lurasidone, a treatment for schizophrenia
FDA warns of intravascular hemolysis risk with WinRho SDF
Botox approved for upper limb spasticity
New Product: SAPHRIS
®
(asenapine) Sublingual Tablets
Pediaderm HC Complete Kit available for atopic dermatitis
Generic timolol maleate ophthalmic gel forming solution available
Xiaflex available for Dupuytren's contracture
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