6 Dec 2013
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FDA advisory committee meeting: Truvada for Pre-Exposure Prophylaxis (PrEP)
Approval of Paradaxa for Stroke Prevention
Botox Injection for Chronic Migraine
Vivitrol Approval for Opioid-Dependent Patients
Breast-Feeding for 6 Months May Prevent Infant Infections
Beyaz: A Combination Contraceptive and Folate
First Oral Drug to Reduce MS Relapses
FDA Approves Lumigan 0.01% Ophthalmic Solution
Schizophrenia Drug Approved for 2 New Uses
FDA Proposes Withdrawal of Low Blood Pressure Drug
US FDA Approves Xeomin
FDA Approves Cuvposa for Chronic Drooling in Children
FDA Approves a New Hypertension Polypill
US FDA Approves Doxepin for Treatment of Insomnia
A new Promising Weight Loss Drug
A New Immunotherapy for Prostate Cancer
A New Rapid Test for Hepatitis C Virus Antibodies
Generic Effexor Extended Release Capsules For Major Depressive Disorder
US FDA approves Jalyn for Benign Prostatic Hypertrophy
OVA1 Test for Ovarian Cancer
New Generic of Starlix
Expanded Indication for Zevalin
Approval of Hiberix Vaccine
Avastin Approved for Renal Cell Carcinoma
Saphris Approval For Schizophrenia and Bipolar Disorder
FDA Approves Sumavel DosePro
WHO Approves Cervical Cancer Vaccine Cervarix
FDA approves Multaq for Atrial Fibrillation and Flutter
Caldolor(TM): An Intravenous Ibuprofen Approved
Ozurdex Approved for Macular Edema Following Retinal Vein Occlusion
First Batch of Swine Flu Vaccine
Besivance Approved for Pink Eye Treatment
FDA Approves Synvisc-One for Knee Osteoarthritis
Expanded FDA approval for Copaxone
RiaSTAP Approved for Congenital Fibrinogen Deficiency
AllerNaze™ Approved for Allergic Rhinitis
Epiduo: A new Combination Acne Gel
Degarelix Approved for Patients with Advanced Prostate Cancer
MPX Test : A First Nucleic Acid Test to Screen for HIV in Donated Blood and Tissue
Apidra(R) Approved for Children With Diabetes Mellitus
Ranexa(R) Approved for the Treatment of Chronic Angina
Approval of Generic Version of UCB Pharma's Keppra(R)
New Indication for Norditropin(R)
A New Drug to Treat Overactive Bladder
USA 2008-2009 Seasonal Influenza Vaccines Approved
Approval of Cardene® Premixed Injection
Approval of First Generic Versions of Divalproex Sodium
A New Warfarin Sensitivity Test
EOVIST(R) Approved to Detect Focal Liver Lesions
A New Genetic Test for Breast Cancer
First Generic Versions of Risperdal Approved
Conditional Marketing Approval Of Tyverb
Amitiza Approved for Irritable Bowel Syndrome with Constipation
FDA Approves Relistor for Opioid- Induced Constipation
FDA Approves Cimzia to Treat Crohn's Disease
Approval of a New Saline Lip Implants for Permanent Cosmetic Lip Augmentation
FDA Approves a New Vaccine against Rotavirus
Approval of Avastin in Combination Chemotherapy for Advanced Breast Cancer Treatment
Arcalyst: A New Orphan Drug for Treatment of Rare Inflammatory Syndromes
Nexium expanded for Use in younger Children
Xyntha: A new Antihemophilic Factor Approved
MIRCERA: A first Monthly Treatment of Anemia for CRF Patients
Zyrtec-D approved as nonprescription drug for allergies
Approval of Combigan Eye Drops for Glaucoma
Voltaren Gel for Osteoarthritis
FDA Approves Antibiotic Ointment for Children and Adults
Ixempra approved for metastatic or locally advanced breast cancer
Menactra use is expanded for younger children
Doripenem approved for treatment of complicated infections
Raltegravir: A new treatment approved for HIV infection
First Generic Versions of Trileptal Approved
New generic Clarithromycin suspension approved.
Lamisil granules approved for pediatric fungal infections
Totect approved for Anthracycline extravasations’ treatment in USA
A New Indication for Evista approved by FDA
FDA Approves Second-Generation Smallpox Vaccine
FDA Approves New Drug to Treat Acromegaly
FDA Approves Human Thrombin for Topical Use in Surgery
Approval of Aliskiren For Hypertension in Europe
First test for return of breast cancer approved
Orlistat: A Diet drug approved for Over-the-Counter Use
FDA Approves New Product to Treat Von Willebrand Disease
Olux-E (TM) Foam approved for Treatment of Psoriasis and Eczema
Invanz approved for surgical site infection prevention in colorectal surgery.
Byetta® approved for expanded combination use in type 2 diabetes
Refrigerated version of FluMist® Vaccine is approved
Invega ® Approved for the treatment of Schizophrenia
Celebrex For Juvenile Rheumatoid Arthritis Treatment
FDA Approval to Market Alaway(TM) for Eye Itch Relief
Chewable Birth Control Pill Now Available
Sprycel® Approved In Europe For Leukemia Treatment.
FDA Approves First Generic Zofran Injection.
MIRAPEX(R) approved for the Treatment of Primary Restless Legs Syndrome.
Use of Aricept for Patients With Severe Alzheimer's Disease
New Drug Application For COPD
Approval of New Indication for YAZ
Duodote an Antidote for civilians exposed to nerve agents.
FDA Approves Vectibix for Colorectal Cancer
Xolegel Approved for Treatment of Skin Inflammation.
Duetact ® approved for treatment of type 2 diabetes.
First generic Ciprofloxacin injection approved.
Approval of Zanamivir in EU for Prevention of Influenza
FDA Approves a New Medical Use for Plavix
Approval of Humira® for Treatment of Ankylosing Spondylitis
Approval of First Generic Simvastatin
Approval of Fentora Buccal Tablet
Approval for Combination Diabetes Preparation by European Union
Approval of Keppra Intravenous Administration
Inhaled insulin (Exubera) launched in the UK
Approval of Oncaspar for Newly-Diagnosed Acute Lymphoblastic Leukemia
Approval of a New Over-the-Counter Sunscreen Product
FDA Approves First Treatment for Hunter Syndrome
Approval of a New Implantable Contraceptive
Approval: Novel Medication for Smoking Cessation
Approval of the First Once-a-Day Combination Tablet for Treatment of HIV-1
Approval: New Biologic Treatment for Wet Age-Related Macular Degeneration
Approval of the First Treatment for Dementia of Parkinson’s Disease
FDA Approval for Generic Proscar® Tablets
Approval of Gardasil , A New Vaccine for Prevention of Cervical Cancer
FDA Approval of Orapred ODT
FDA approved Omnitrope
Approval: New Vaccine for Shingles
Approval: Fexofenadine Hydrochloride tablets.
AZILECT(R) approved for treatment of Parkinson' disease.
Chantix® tablets have been approved by FDA to stop smoking.
Dacogen approved for treatment of MDS.
Nexium is approved by FDA in children ages 12 to 17 for short-term treatment of GERD.
Pompe's Disease Treatment Licensed.
An IND approval for the Novel Cancer Drug AT9283.
FDA Approves Every-Three-Week Dosing of Aranesp(R) to Treat Chemotherapy-Induced Anemia.
Taxotere ® in combination is approved for advanced stomach cancer.
FDA rejects Marijuana for medical use.
Vivitrol® Monthly drug for alcoholism gets FDA approval
Daytrana ® First Attention Deficit Patch approved BY FDA.
Relenza ®: A drug approved for Influenza A & B prevention.
Prograf ® approved to prevent rejection in heart transplantations.
Terconazole: Vaginal suppositories approved by FDA.
Yaz ®: An Oral Contraceptive approved.
Zegerid ®: First immediate-release PPI capsule approved.
Emsam ® (Selegiline): A First Drug Patch approved for Depression.
Aclasta® in the process of FDA approval for the treatment of Paget’s disease.
FDA OKs Generic Version of Flonase®
FDA Approves Oral Rotavirus Vaccine.
Amitiza ® approved for Treatment of Chronic
Sutent®: A new treatment for gastrointestinal and kidney cancer approved by FDA.
FDA approves Boniva ® as a first intravenous osteoporosis drug.
VAPRISOL® approved for the treatment of Euvolemic Hyponatremia.
Revlimid approved for treatment of Myelodysplastic Syndrome (MDS).
FDA Approves Nexavar for Kidney Cancer.
FDA Grants Priority Review to Taxotere® for the Supplemental New Drug Application for Advanced Gastric Cancer.
Avelox® (Moxifloxacin HCl) approved for intra-abdominal infections.
FDA Approves Effexor XR® for Panic Disorder Treatment.
FDA Fast-Tracked Proxinium™ for Head and Neck cancer.
Tarceva ® Approved for Advanced Pancreatic Cancer
Exenatide Approved For Type 2 Diabetes
Intravitreal Fluocinolone Implant Approved For Uveitis
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