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October, 2010
October, 2010:
Sandoz recalls certain lots of Methotrexate Injection
Latuda approved for schizophrenia
Sprycel gains indication for Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML)
B. Braun recalls seven lots of heparin
Orazyme Dry Mouth Mouthwash for xerostomia
Phase 2 study of CPX-351 for the treatment of acute myeloid leukemia (AML)
Phase 2 study of ataluren for the treatment of nonsense mutation methylmalonic acidemia (nmMMA)
Phase 2 study of rHuPH20 for type 1 and type 2 diabetes
Phase 3 trial of lixisenatide for treatment of type 2 diabetes
Phase 3 study of linagliptin for treating type 2 diabetes
Phase 3 trial of dapagliflozin plus metformin for type 2 diabetes
Phase 2 study of Androxal for type 2 diabetes in hypogonadal men
FDA issues complete response letter to NDA for lorcaserin
Phase 3 trials of fidaxomicin for the treatment of Clostridium difficile infection (CDI)
REMS approved for Nuvigil and Provigil
Hyland's Teething Tablets recalled
Lo Loestrin FE oral contraceptive approved
Invirase labeling updated to include cardiac risk with Norvir
Fentanyl transdermal 25mcg/hr patches recalled
GnRH agonists labeling updated to include diabetes and cardiovascular risk
Herceptin approved for HER2-positive metastatic stomach cancer
Pradaxa approved for stroke risk reduction
Phase 2 trial of CAL-101 for the treatment of chronic lymphocytic leukemia (CLL)
Tylenol 8 Hour caplets recalled
Preservative-free Garamycin ophthalmic ointment available
Baraclude approved for chronic hepatitis B with decompensated liver disease
Bromday approved for post-cataract extraction inflammation and ocular pain reduction
Botox gains indication for chronic migraine
H.P. Acthar Gel approved for infantile spasms
FDA approves REMS for Gabitril
FDA warns against over-the-counter chelation products
Bisphosphonates labeling updated to include atypical fractures warning
Vivitrol approved for opioid dependence
Phase 2 trial of brentuximab vedotin for the treatment of anaplastic large cell lymphoma (ALCL)
Phase 2 trial of GDC-0449 for the treatment of operable basal cell carcinoma (BCC)
Systane Balance lubricant eye drops for Meibomian Gland Dysfunction
Cefepime now available for use in DUPLEX Drug Delivery System
FDA approves Atelvia for osteoporosis
FDA warns against Slimming Beauty Bitter Orange Slimming Capsules
MPR Everywhere Contest winner
Meridia to be withdrawn from market
MPR Everywhere Contest - Honorable Mention
MPR Everywhere Contest - Funniest Entries
Phase 2 study of AGS-003 for the treatment of metastatic renal cell carcinoma (mRCC)
Phase 3 study of Vectibix for the treatment of metastatic colorectal cancer (mCRC)
Phase 2 study of tasocitinib for the treatment of plaque psoriasis
Phase 3 study update of D-tagatose for type 2 diabetes
Aridol Bronchial Challenge Test Kit approved
Tamiflu available for 2010-2011 influenza season
Phase 2a study of plecanatide for the treatment of chronic constipation (cc)
VeriPsych schizophrenia diagnostic aid available
Xeomin available for cervical dystonia and blepharospasm
Suprep Bowel Prep Kit available
Kapvay approved for ADHD
FDA halts marketing of unapproved colchicine
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