Shipments of Horizant ER tablets have commenced, and are expected to be available to patients in the first week of June.
The WHO's expert advisory group on immunization has concluded that a single dose of the yellow fever vaccine is sufficient to confer lifelong immunity against yellow fever disease.
The FDA has granted sebelipase alfa Breakthrough Therapy designation for the treatment of early onset lysosomal acid lipase deficiency.
NuVision Pharmacy of Dallas, TX is expanding its recall of all sterile drug products after a recent FDA inspection at its facility.
Pentec Health is recalling unused nutritional prescriptions for renal patients compounded on or before May 2, 2013.
Transition of Combivent Respimat is nearly complete as Boehringer Ingelheim plans to cease distribution of Combivent MDI in May.
Genetech announced results from CLL11, a Phase 3 study of obinutuzumab (GA101), comparing the combination of either obinutuzumab or Rituxan and chlorambucil to chlorambucil alone in chronic lymphocytic leukemia (CLL).
The FDA has approved Simponi (golimumab for subcutaneous injection; Janssen Biotech) to induce and maintain clinical response in adults with ulcerative colitis.
The FDA has approved Bayer's Xofigo for the treatment of advanced prostate cancer with bone metastases.
The cobas EGFR Mutation Test has been approved to identify patients with non-small cell lung cancer who are candidates for receiving Tarceva as first-line treatment.
The FDA has approved new dosing recommendations for zolpidem-containing products for the treatment of insomnia.
The FDA has approved a new oral formulation to help reduce fatal medication errors in improving outcome for patients with subarachnoid hemorrhage.
The FDA has accepted Seattle Genetics' sBLA for filing of Adcetris for retreatment and extended duration beyond 16 cycles of therapy in relapsed Hodgkin lymphoma and systemic anaplastic large cell lymphoma.
The FDA has accepted the Biologics License Application for Eloctate, a first in class recombinant factor VIII Fc fusion protein for hemophilia A treatment.
The FDA has granted Janssen R&D's NDA priority review for simeprevir in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults.
The FDA has accepted for filing Actavis' NDA for a once-weekly progestin-only transdermal contraceptive patch to prevent pregnancy in women.
Apotex, on behalf of Hospira, is recalling an additional 21 lots of Piperacillin/Tazobactam for Injection due to possible precipitation and crystallization in IV bag or line after reconstitution.
Breo Ellipta is a novel combination inhaler indicated for the maintenance of COPD, including chronic bronchitis and/or emphysema.
Mainly affecting eastern China, the number of bird flu cases has risen to 102, including 20 deaths. This is the first time that this flu subtype, influenza A (H7N9) virus, has been found in people.
Ilaris is the first interleukin-1 beta inhibitor approved for the treatment of systemic juvenile idiopathic arthritis.
Atriphen has been recalled due to the possibility of causing a severe allergic reaction from two undeclared allergens.
For preoperatively depressed patients undergoing coronary artery bypass grafting (CABG), antidepressant therapy has no impact on morbidity or mortality, but is associated with improvements in measures of depression and mental health quality-of-life.
Alcon announced the FDA approval of Simbrinza Suspension, a new beta-blocker-free, fixed-combination therapy for patients with glaucoma.
Since April 2012, a novel coronavirus (NCoV) has infected 31 adults in six countries.
Possible microbial contamination in sterile compounds from The Compounding Shop poses a risk of serious infection to patients.
For preterm infants, administration of the monoclonal antibody palivizumab for prevention of respiratory syncytial virus (RSV) infection is associated with a significant reduction in the number of days of wheezing during the first year of life.
The FDA has accepted for review the Biologics License Application for ragweed pollen sublingual allergy immunotherapy tablet.
The FDA warns the public to stop using three male sexual enhancement products after finding undeclared drug ingredients such as tadalafil.
Aviir announced the expansion of their comprehensive inherited cardiovascular disease genetic test services.
Phase 3 trial evaluating Vectibix vs. Erbitux for the treatment of chemo-refractory metastatic colorectal cancer meets its primary endpoint for overall survival.
Oncotype DX, the first-of-its-kind biopsy-based prostate cancer test, is now available to help physicians and their patients choose the most appropriate treatment.
The endothelin A receptor-selective antagonist ambrisentan is not effective for reducing the rate of idiopathic pulmonary fibrosis progression.
Baxter's immunoglobulin study for the treatment of Alzheimer's has been discontinued after a Phase 3 study failed to meet co-primary endpoints.
TriMix has launched TriMix-gel, an erectile dysfunction medication for patients who cannot tolerate self-injection with a needle or have failed PDE5 inhibitor therapy.
Antibiotic candidate, ceftolozane/tazobactam, has been granted Fast Track Status for the treatment of hospital-acquired bacterial pneumonia/ acquired bacterial pneumonia and complicated urinary tract infections.
The FDA advises pregnant women against using valproate products to prevent migraines based on final results of the Neurodevelopmental Effects of Antiepileptic Drugs (NEAD) study.
The FDA is alerting health care professionals of possible medication errors resulting from confusing generic names for Kadcyla (ado-trastuzumab emtansine) and Herceptin (trastuzumab).
SD-101 was granted Breakthrough Therapy designation for the treatment of skin blisters and erosions caused by Epidermolysis Bullosa.
Pfizer has launched Viagra home delivery, a new website where patients can fill their Viagra prescriptions from a trusted online source.
Aurstat Anti-Itch Hydrogel, a non-steroidal treatment from Onset Dermatologics, provides relief of pain, burning, and itching associated with various dermatoses.
NIH study showed metreleptin treatment reduced HbA1c, triglycerides, and liver function tests in children and adolescents with lipodystrophy during a 12-month period.
AbbVie was granted Breakthrough Therapy designation for it's direct-acting antiviral combination regimen with and without ribavirin for the treatment of genotype 1 HCV.
Clearblue Advanced Pregnancy Test with Weeks Estimator not only tells a woman if she is pregnant but also estimates the number of weeks since ovulation.
The FDA has approved Liptruzet, combination of ezetimibe and atorvastatin, for the treatment of elevated LDL cholesterol in patients with primary or mixed hyperlipidemia and homozygous familial hypercholesterolemia as an adjunct to diet.
Taking low-dose oral contraceptives may increase the risk of pelvic pain symptoms and pain during sexual climax.
The CDC reports a statistically significant increase in suicide rates among individuals 35-64 years old. The report's finding indicates a need for suicide research and prevention efforts in middle-aged Americans.
UroSketch 3D, a mobile app from GenomeDx Biosciences, is now available for urologists to help aid patient consultations. The app provides 3D models of the prostate, bladder, and surrounding organs.
The FDA approved an sNDA for Sustiva expanding the age and weight based dosing recommendations for HIV-1 infected pediatric patients. This new approval also provides a "capsule sprinkle" administration method.
New AUA guidelines for prostate cancer screenings increase the recommended age from 40 to 55, and recommend screenings every two years instead of annually.
The FDA has approved Vyvanse capsules for the maintenance treatment in children and adolescents ages 6 years and older with ADHD. Vyvanse is already approved to treat ADHD in adults and children.
Santarus and VeroScience announced the inclusion of Cycloset as a therapy for patients with type 2 diabetes in a new diabetes management algorithm published by the American Association of Clinical Endocrinologists.
Forest Laboratories and Almirall announced positive top line results from AUGMENT COPD, the second six-month Phase 3 clinical trial evaluating the safety and efficacy of investigational fixed dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA) delivered in the Pressair inhaler.
Janssen Research & Development announced that the FDA granted daratumumab Breakthrough Therapy Designation for the treatment of patients with multiple myeloma.
Lymphoseek Injection is now available for use in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek was approved by the FDA in March 2013.
Lantheus Medical Imaging announced that an interim analysis of the first of two Phase 3 studies has met the criteria for completion for its Phase 3 flurpiridaz F 18 clinical program.
The FDA approved an amended application to market Teva's Plan B One-Step for use without a prescription by women 15 years or older.
Cystaran (cysteamine ophthalmic solution; Sigma-Tau) is the first FDA-approved therapy for the treatment of corneal cystine crystal accumulation in patients with cystinosis.
Omeros Corporation announced that it has requested Fast Track Designation from the FDA for the development of OMS824 for the treatment of Huntington's disease.
The FDA has approved Procysbi delayed-release capsules for the treatment of nephropathic cystinosis in patients 6 years or older. The approval is based on data from six clinical trials.
After discovering increased risk of liver injury during recent trials, the FDA says that Samsca tablets should only be used for a short duration and not in patients with underlying liver disease.
Prometheus Anser ADA, a novel test to measure adalimumab and its antibody levels in one serum sample, will aid treatment decisions for patients with inflammatory bowel disease who are taking adalimumab.
A voluntary nationwide recall has been issued for 15 lots of Piperacillin and Tazobactam for Injection 40.5g. Administration of precipitated Piperacillin/Tazobactam in an IV bag or IV line may result in phlebitis, renal impairment, end-organ embolism and ischemia, and/or vasculitis.
Kcentra (CSL Behring) has been approved by the FDA for warfarin reversal during acute major bleeding. Kcentra does not require blood group typing or thawing, so it can be administered more quickly than frozen plasma.
Three major updates were added to the prescribing information for Pradaxa capsules, an oral anticoagulant. One included a warning that discontinuing treatment puts patients at increased risk of stroke.
Octapharma U.S.A. announced that the FDA has accepted for review its Biologic License Application (BLA) for octaplex for the reversal of anticoagulation in patients undergoing vitamin K antagonist therapy with the need for urgent surgery or invasive procedures.
The FDA is warning that long-term use of GlaxoSmithKline's Potiga can cause blue skin discoloration and pigment changes in the retina. It is not yet known if these changes are reversible.
Gilead Sciences announced that it has received Complete Response Letters from the FDA for its New Drug Applications (NDAs) for elvitegravir and cobicistat for use as part of HIV treatment regimens.
Hospira had notified the public last August that it initiated a voluntary nationwide user-level recall of one lot of 0.9% Sodium Chloride Injection, USP, 100mL, Flexible Container, NDC 0409-7984-23. Hospira is investigating the root cause.
Saratoga Therapeutics recalled 900 bottles of ebA Multivitamin Supplement because they may contain undeclared milk components such as milk protein(s) and lactose.
The FDA is advising consumers not to purchase or use sexual enhancement products Sex Plus and Zoom-Zooma-Zoom. Laboratory analysis confirmed that the products contain undeclared ingredients such as sildenafil and tadalafil.
Genzyme announced positive top-line results from the TOPIC trial for Aubagio, which assessed whether early initiation of the medication in patients who experienced their first neurological symptoms consistent with Clinically Isolated Syndrome can prevent or delay conversion to clinically definite multiple sclerosis.
Fumaric acid or fumarate-induced lymphopenia may contribute to the development of progressive multifocal encephalopathy.
The FDA has designated Merck's lambrolizumab (MK-3475) as Breakthrough Therapy for the treatment of patients with advanced melanoma. Lambrolizumab is an investigational antibody therapy targeting Programmed Death receptor.
New data has been released from an interim analysis of the exploratory global Phase 3b CONCISE study evaluating the potential to shorten total treatment with telaprevir combination therapy to 12 weeks in certain people with genotype 1 chronic hepatitis C virus infection who have the IL28B CC genotype.
Nora Apothecary and Alternative Therapies issued a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached expiry that were compounded and dispensed on or before April 19, 2013.
Boehringer Ingelheim announced results from the pivotal Phase 3 STARTVerso 1 trial of faldaprevir in combination with pegylated interferon and ribavirin. Faldaprevir is an oral protease inhibitor that is designed to target viral replication in the liver.
The FDA has granted Orphan Drug designation to Teva Pharmaceutical and Xenon Pharmaceutical's investigation drug XEN402, which is being developed for the treatment of pain associated with erythromelalgia.
The FDA has fast-tracked the investigation of Sanofi Pasteur's KB001A, an antibody fragment intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa in mechanically-ventilated patients. Phase 1 trial of KB001A in underway in the U.S.; planning for a Phase 2b study has begun.
The FDA has accepted Amarin's Supplemental New Drug Application seeking approval for the marketing and sale of Vascepa capsules as an adjunct to diet in the treatment of adult patients with high triglycerides with mixed dyslipidemia.
The FDA has approved Sucampo and Takeda's supplemental New Drug Application for Amitiza to treat opioid-induced constipation in adults with chronic non-cancer pain. Amitiza is already indicated for treating irritable bowel syndrome and chronic idiopathic constipation.
For HER2-mutated non-small-cell lung cancer, half of tumors are detected at stage IV, and anti-human epidermal growth factor receptor 2 (HER2) treatments are associated with encouraging response rates and disease control rates.
Due to concerns with quality control processes, Balanced Solutions Compounding Pharmacy issued a voluntary recall of all lots of sterile products compounded by the pharmacy that are not expired.
Between January 2011 and January 2013, the FDA received 458 reports associated with medical bed mattress covers failing to prevent blood and body fluids from leaking into the mattress. Damaged and soiled mattresses can be a source of contamination during infection outbreaks.
Braintree Laboratories has launched Suclear, a new bowel prep product. Suclear is a combination of osmotic laxatives and is indicated for colon cleansing in preparation for colonoscopy in adults.
The FDA has approved Abbott's Tecnis Toric 1-piece intraocular lens for the visual correction of aphakia and pre-existing corneal astigmatism. The Tecnis Toric lenses are indicated in adult patients with or without presbyopia in whom a cataractous lens has been removed by phacoemulsification.
UCB announced the introduction of Cimzia Starter Kit for induction dosing. Cimzia is a pegylated anti-TNF indicated for the treatment of adults with moderately to severely active rheumatoid arthritis or Crohn's disease.
GlaxoSmithKline is currently experiencing a shortage of Horizant 600mg extended-release tablets, according to the FDA. Horizant is a prodrug of gabapentin that is indicated for postherpetic neuralgia and for moderate-to-severe primary restless legs syndrome in adults.
Omeros has filed an Application for Orphan Drug Designation with the FDA for OMS721, the lead human monoclonal antibody in Omeros' mannan-binding lectin-associated serine protease-2 program, for use in the treatment of atypical hemolytic uremic syndrome.
Teva released data from a sub-analysis of a Phase 3 clinical trial of Milprosa vaginal ring, an investigational, once-weekly therapy for luteal phase support in women undergoing in vitro fertilization.
As part of an effort to combat misuse, the FDA has approved updated labeling for Purdue Pharma's reformulated OxyContin controlled-release tablets. The reformulated tablet is more difficult to crush, break, or dissolve, which may reduce therapeutic misuse.
The FDA has approved Vivus, Inc.'s amendment and modification to the Risk Evaluation and Mitigation Strategy for Qsymia extended-release capsules. This amendment allows Qsymia to be dispensed through certified retail pharmacies in addition to the existing certified mail-order pharmacies.
Almirall and Forest Laboratories announced positive results from a six-month pivotal Phase 3 clinical trial evaluating the efficacy and safety of fixed dose combinations of aclidinium bromide, a long-acting muscarinic antagonist and formoterol fumarate, a long-acting beta-agonist delivered by Almirall's inhaler Pressair.
Durect Corporation has submitted a New Drug Application to the FDA for the investigational product Posidur, a post-operative pain relief depot that utilizes Durect's patented Saber technology to deliver bupivacaine.
Eli Lilly revealed positive top-line results of two additional Phase 3 AWARD trials for dulaglutide, an investigational, long-acting glucagon-like peptide 1 receptor agonist being studied as a once-weekly treatment for type 2 diabetes.
The FDA has issued a Complete Response Letter to Allergan's New Drug Application for Levadex inhalation aerosol, which is indicated for the acute treatment of migraines in adults.
Echosens' FibroScan device, used in the clinical management of patients with liver disease such as chronic viral hepatitis C and B and fatty liver diseases, has received clearance from the FDA.
The FDA is alerting health care providers, hospital supply managers, and pharmacists to immediately check and quarantine any sterile products from ApotheCure or sterile lyophilized products from NuVision Pharmacy. They may have a high potential for contamination.
BioAlliance Pharma has received marketing authorization from the FDA for Sitavig in the treatment of recurring Herpes labialis. Sitavig is a nucleoside analog that comes in the form of a mucoadhesive tablet.
Due to a problem with incorrect test results at extremely high blood glucose levels, Abbott issued a voluntary recall for FreeStyle InsuLinx blood glucose meters in the U.S. No other Abbott blood glucose meters are affected by this issue.
Taro Pharmaceuticals has received FDA approval for its New Drug Application for Topicort Topical Spray, a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years and older.