News and Events
Monthly News Roundup - September 2017FDA Approves Lilly’s Verzenio: Targeted Breast Cancer Treatment
Lilly’s Verzenio (abemaciclib), a CDK 4/6 inhibitor breast cancer treatment, has been FDA-approved. Verzenio is used in 2 patient populations: either with fulvestrant (Faslodex)...FDA Improves Access to Reports of Adverse Drug ReactionsSeptember 28, 2017 -- The U.S. Food and Drug Administration today launched a new user-friendly search tool that improves access to data on adverse events associated with drug and biologic products through the FDA’s Adverse Event Reporting System...FDA Approves First Continuous Glucose Monitoring System for Adults Not Requiring Blood Sample CalibrationSeptember 27, 2017 -- The U.S. Food and Drug Administration today approved the FreeStyle Libre Flash Glucose Monitoring System, the first continuous glucose monitoring system that can be used by adult patients to make diabetes treatment decisions...FDA Conducts Major Global Operation to Protect Consumers From Potentially Dangerous Prescription Drugs Sold OnlineSeptember 25, 2017 -- The U.S. Food and Drug Administration, in partnership with international regulatory and law enforcement agencies, recently took action against more than 500 websites that illegally sell potentially dangerous, unapproved...Teva Announces Reintroduction of Generic Depo-Provera in the United StatesJERUSALEM--(BUSINESS WIRE)--Sep. 25, 2017-- Teva Pharmaceutical Industries Ltd., (NYSE: TEVA) today announced the reintroduction of the generic equivalent to Depo-Provera1 Contraceptive Injection (medroxyprogesterone acetate injectable suspension,...Criminal and Civil Actions Filed Against Aegerion Pharmaceuticals Inc.September 22, 2017 -- Today, Aegerion Pharmaceuticals Inc. agreed to plead guilty in the United States District Court for the District of Massachusetts to two misdemeanor counts of violating the Federal Food, Drug, and Cosmetic Act (FD&C Act)...Monthly News Roundup - August 2017Kymriah from Novartis Approved as First U.S. CAR-T Cell Therapy
History was made this month as the U.S. Food and Drug Administration (FDA) approved the first U.S. cell-based gene therapy known collectively as chimeric antigen receptor (CAR)...FDA provides new tools for the development and proper evaluation of tests for detecting Zika virus infectionAugust 17, 2017 -- As an additional measure in the fight against Zika virus, today the U.S. Food and Drug Administration announced that it has made available a panel of human plasma samples to aid in the regulatory evaluation of serological tests to...FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary SupplementsAugust 11, 2017 -- The U.S. Food and Drug Administration is advising consumers and health care professionals not to use any liquid drug or dietary supplement products manufactured by PharmaTech LLC of Davie, Florida, and labeled by Rugby...Monthly News Roundup - July 2017FDA Approves Gilead’s Vosevi for Six Hepatitis C Genotypes
The U.S. Food and Drug Administration (FDA) has approved Gilead’s Vosevi (sofosbuvir, velpatasvir and voxilaprevir) for retreatment of adults with chronic hepatitis C virus (HCV) of...FDA Clears First Neonatal Magnetic Resonance Imaging DeviceJuly 20, 2017 -- Today, the U.S. Food and Drug Administration cleared the first magnetic resonance imaging (MRI) device specifically for neonatal brain and head imaging in neonatal intensive care units (NICU).
“Although we can use traditional MRI...Endo Provides Update On Opana ERDUBLIN, July 6, 2017 /PRNewswire/ -- Endo International plc (NASDAQ: ENDP) continues to believe in the safety, efficacy, and favorable benefit-risk profile of Opana ER (oxymorphone hydrochloride extended release) when used as intended, and notes...FDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During ChemotherapyJuly 3, 2017 -- Today, the U.S. Food and Drug Administration cleared the expanded use of a cooling cap, DigniCap Cooling System, to reduce hair loss (alopecia) during chemotherapy. This is the first cooling cap cleared by the agency for use in...Monthly News Roundup - June 2017New Fluoroquinolone Baxdela Approved for Certain Skin Infections
Roughly 3 million patients are hospitalized each year in the U.S. with acute bacterial skin and skin structure infections (ABSSSIs), some of which may be difficult-to-treat and...FDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and LymphomasJune 29, 2017 -- The U.S. Food and Drug Administration today allowed marketing of ClearLLab Reagents (T1, T2, B1, B2, M), the first agency authorized test for use with flow cytometry to aid in the detection of several leukemias and lymphomas,...FDA Unveils Plan to Eliminate Orphan Designation BacklogJune 29, 2017 -- Today, the U.S. Food and Drug Administration unveiled a strategic plan to eliminate the agency’s existing orphan designation request backlog and ensure continued timely response to all new requests for designation with firm...FDA Tackles Drug Competition to Improve Patient AccessJune 27, 2017 -- Today, the U.S. Food and Drug Administration is taking two new, important steps to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. The agency published a list of off-patent,...Sonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved DrugsJune 15, 2017 -- Today, U.S. District Judge Kathleen M. Williams for the Southern District of Florida entered a consent decree of permanent injunction between the United States and Stratus Pharmaceuticals Inc. of Miami, Florida, Sonar Products Inc....FDA Requests Removal of Opana ER for Risks Related to AbuseJune 8, 2017 -- Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is...FDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)June 8, 2017 - The U.S. Food and Drug Administration has approved the first generic version of Truvada for the treatment of HIV-1, in combination with other antiretroviral agents, and for pre-exposure prophylaxis (PrEP) in combination with safer sex...Monthly News Roundup - May 2017Actemra: First Drug Approved to Treat Giant Cell Arteritis
Actemra (tocilizumab) from Hoffman La Roche has gained a new indication as the first drug approved to treat adults with giant cell arteritis, a specific type of vasculitis. Vasculitis is...FDA Approves First Generic Strattera for the Treatment of ADHDMay 30, 2017 -- The U.S. Food and Drug Administration today approved the first generic versions of Strattera (atomoxetine) to treat attention-deficit/hyperactivity disorder (ADHD) in pediatric and adult patients.
Apotex Inc., Teva Pharmaceuticals...FDA Warns Americans About Risk of Inaccurate Results from Certain Lead TestsMay 17, 2017 -- The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in...FDA Authorizes Use of New Device to Treat Esophageal Birth Defect in BabiesMay 12, 2017 -- The U.S. Food and Drug Administration today authorized use of the Flourish Pediatric Esophageal Atresia Anastomosis, a first-of-its-kind medical device to treat infants up to one year old for a birth defect that causes a gap in their...Monthly News Roundup - April 2017Takeda Announces FDA Accelerated Approval of Alunbrig
The US Food and Drug Administration (FDA) has approved once-daily oral Alunbrig (brigatinib) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small...FDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric PatientsApril 7, 2017 -- The U.S. Food and Drug Administration today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to treat hepatitis C virus (HCV) in children ages 12 to 17. Harvoni and Sovaldi were...FDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain ConditionsApril 6, 2017 -- The U.S. Food and Drug Administration today allowed marketing of 23andMe Personal Genome Service Genetic Health Risk (GHR) tests for 10 diseases or conditions. These are the first direct-to-consumer (DTC) tests authorized by the FDA...FDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen JrMarch 31, 2017 -- The U.S. Food and Drug Administration is alerting consumers to Meridian Medical Technologies’ voluntary recall of 13 lots of Mylan’s EpiPen and EpiPen Jr (epinephrine injection) Auto-Injector products used for emergency...Monthly News Roundup - March 2017Ocrevus Approved for Novel Use Among Multiple Sclerosis Treatments
The much anticipated multiple sclerosis (MS) treatment Ocrevus (ocrelizumab) was given the green light from the FDA this month. Ocrevus is a humanized monoclonal antibody designed...Monthly News Roundup - February 2017FDA Approves Once-Daily Qtern Tablets for Adults with Type 2 Diabetes
The U.S. Food and Drug Administration (FDA) has cleared AstraZeneca’s Qtern (dapagliflozin and saxagliptin), a sodium-glucose cotransporter 2 (SGLT2) inhibitor and dipeptidyl...FDA Clears Test to Help Manage Antibiotic Treatment for Lower Respiratory Tract Infections and SepsisFebruary 23, 2017 -- The U.S. Food and Drug Administration today cleared the expanded use of the Vidas Brahms PCT Assay to help health care providers determine if antibiotic treatment should be started or stopped in patients with lower respiratory...FDA Allows Marketing of Test to Identify Organisms That Cause Bloodstream Infections and Provide Antibiotic Sensitivity ResultsFebruary 23, 2017 -- The U.S. Food and Drug Administration today allowed marketing of the PhenoTest BC Kit, performed on the Pheno System. This is the first test to identify organisms that cause bloodstream infections and provide information about...Louisiana Drug and Dietary Supplement Maker Ordered to Cease Operations Due to Federal ViolationsFebruary 21, 2017 -- On Friday, U.S. District Judge Robert G. James for the U.S. District Court for the Western District of Louisiana entered a consent decree of permanent injunction against Pick and Pay Inc./Cili Minerals, a manufacturer and...Monthly News Roundup - January 2017Trulance Cleared by FDA for Chronic Idiopathic Constipation (CIC)
The U.S. Food and Drug Administration (FDA) has approved Synergy’s Trulance (plecanatide), a uroguanylin analog for the treatment of chronic idiopathic constipation (CIC)....FDA Approves Xyrem (sodium oxybate) Oral Solution Generic with a REMS ProgramJanuary 18, 2017 -- The FDA has approved the first generic version of Xyrem (sodium oxybate) Oral Solution, to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy, which is a potentially debilitating disease. Cataplexy is a...Monthly News Roundup - December 2016Biogen’s Spinraza Approved for Spinal Muscular Atrophy
The U.S. Food and Drug Administration (FDA) has cleared Biogen's Spinraza (nusinersen), the first drug for spinal muscular atrophy (SMA), a rare and often fatal genetic disease affecting...Monthly News Roundup - November 2016Novo Nordisk’s Xultophy 100/3.6 FDA-Approved for Type 2 Diabetes
This month the U.S. Food and Drug Administration (FDA) approved Novo Nordisk’s Xultophy 100/3.6 (insulin degludec and liraglutide), a once-daily injection of insulin degludec...Monthly News Roundup - October 2016Merck’s Zinplava Approved to Fend Off Return of Clostridium Difficile
Zinplava (bezlotoxumab) has been FDA-approved to reduce the recurrence of Clostridium difficile infection (CDI) in adults who are receiving antibacterial drug treatment for...Monthly News Roundup - September 2016Amjevita, a Biosimilar to Humira, Wins FDA Approval
Amgen’s Amjevita (adalimumab-atto) is the first adalimumab (Humira) biosimilar approved by the U.S. Food and Drug Administration (FDA) and is used for the treatment of seven inflammatory...Monthly News Roundup - August 2016FDA Approves Erelzi: Sandoz’s Biosimilar For Enbrel
A third U.S. biosimilar has been FDA-approved; this time it’s Erelzi (etanercept-szzs), a biosimilar to Amgen’s tumor necrosis factor (TNF) blocker Enbrel. Sandoz’s Erelzi is the first...