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FDA Warns of Potential Contamination in Multiple Brands of Drugs, Dietary Supplements
Posted 7 days ago in Pharma Industry News
August 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 Laboratories, Major Pharmaceuticals and Leader Brands, due to potential contamination with the bacteria Burkholderia cepacia (B. cepacia) and the risk for severe patient infection. The drug and dietary supplement products made by PharmaTech include liquid...
Read moreMonthly News Roundup - July 2017
Posted 2 weeks ago in Pharma Industry News
FDA 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 two types: either genotype 1, 2, 3, 4, 5, or 6 previously treated with an NS5A inhibitor regimen, or genotype 1a or 4 previously treated with a sofosbuvir regimen without an NS5A inhibitor. Vosevi, given once daily, is used in patients without cirrhosis or...
Read moreFDA Clears First Neonatal Magnetic Resonance Imaging Device
Posted 4 weeks ago in Pharma Industry News
July 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 scanners to image neonates, taking babies outside of the neonatal intensive care unit to MRI suites presents great challenges,” said Vasum Peiris, M.D., M.P.H., chief medical officer for pediatrics and special populations at FDA’s Center for Devices an...
Read moreEndo Provides Update On Opana ER
Posted 6 weeks ago in Pharma Industry News
DUBLIN, 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 that the Company has taken significant steps over the years to combat misuse and abuse. Nevertheless, after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the Company has decided to voluntarily...
Read moreFDA Clears Expanded Use of Cooling Cap to Reduce Hair Loss During Chemotherapy
Posted 6 weeks ago in Pharma Industry News
July 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 cancer patients with solid tumors. “We are pleased to expand the use of this product for cancer patients with solid tumors to potentially minimize chemotherapy-induced hair loss,” said Binita Ashar, M.D., director, Division of Surgical Devices, in the F...
Read moreMonthly News Roundup - June 2017
Posted 7 weeks ago in Pharma Industry News
New 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 show antibiotic resistance. In response, the FDA has approved Baxdela (delafloxacin), an oral and intravenous (IV) fluoroquinolone antibiotic. Baxdela targets both gram-positive and gram-negative bacteria, including the serious pathogen MRSA...
Read moreFDA Allows Marketing of Test to Aid in the Detection of Certain Leukemias and Lymphomas
Posted 7 weeks ago in Pharma Industry News
June 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, including chronic leukemia, acute leukemia, non-Hodgkin lymphoma, myeloma, myelodysplastic syndrome (MDS) and myeloproliferative neoplasms (MPN). “This represents a major step forward for the hematology-oncology community,” said Alberto Gutierrez, Ph....
Read moreFDA Unveils Plan to Eliminate Orphan Designation Backlog
Posted 7 weeks ago in Pharma Industry News
June 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 deadlines. The agency’s Orphan Drug Modernization Plan comes a week after FDA Commissioner Scott Gottlieb committed to eliminating the backlog within 90 days and responding to all new requests for designation within 90 days of receipt during his testimony bef...
Read moreFDA Tackles Drug Competition to Improve Patient Access
Posted 7 weeks ago in Pharma Industry News
June 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, off-exclusivity branded drugs without approved generics, and also implemented, for the first time, a new policy to expedite the review of generic drug applications where competition is limited. These actions are among the first taken under the...
Read moreSonar Products Ordered to Cease Operations, Stratus Pharmaceuticals Ordered to Cease Distributing Unapproved Drugs
Posted 9 weeks ago in Pharma Industry News
June 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. of Carlstadt, New Jersey and two of the companies’ officers, Alberto Hoyo and Juan Carlos Billoch. According to the complaint filed with the consent decree, Stratus and Sonar routinely shipped unapproved, improperly labeled (misbranded), and s...
Read moreFDA Requests Removal of Opana ER for Risks Related to Abuse
Posted 10 weeks ago in Pharma Industry News
June 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 seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of...
Read moreFDA Approves First Generic Truvada for HIV Infection and Pre-Exposure Prophylaxis (PrEP)
Posted 10 weeks ago in Pharma Industry News
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 practices to prevent sexually-acquired HIV infection in adults at high risk. PrEP may be part of a comprehensive HIV prevention strategy that includes safer sex practices, such as consistent and correct condom use, regular HIV testing and risk...
Read moreMonthly News Roundup - May 2017
Posted 11 weeks ago in Pharma Industry News
Actemra: 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 a group of disorders that leads to swelling of blood vessels. In a clinical study of 251 patients with giant cell arteritis, the primary endpoint, defined as the proportion of patients achieving sustained remission from Weeks 12 to 52, was met....
Read moreFDA Approves First Generic Strattera for the Treatment of ADHD
Posted 11 weeks ago in Pharma Industry News
May 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 USA Inc., Aurobindo Pharma Limited and Glenmark Pharmaceuticals Limited today gained approval to market atomoxetine in multiple strengths. "Today’s approvals mark an important step forward in bringing consumers additional treatments that have met t...
Read moreFDA Warns Americans About Risk of Inaccurate Results from Certain Lead Tests
Posted 13 weeks ago in Pharma Industry News
May 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 the United States. The CDC recommends that parents of children younger than six years (72 months) of age, and currently pregnant women and nursing mothers who have been tested for lead exposure consult a health care professional about whether they...
Read moreFDA Authorizes Use of New Device to Treat Esophageal Birth Defect in Babies
Posted 14 weeks ago in Pharma Industry News
May 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 esophagus, called esophageal atresia. An estimated 1 in every 2,500 babies in the U.S. is born with esophageal atresia. Babies with this condition cannot feed normally, and they require a feeding tube until surgery can be performed to attach the...
Read moreMonthly News Roundup - April 2017
Posted 15 weeks ago in Pharma Industry News
Takeda 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 cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib (Xalkori). In the pivotal Phase 2, open-label ALTA study which enrolled 222 patients, the overall response rate after a median follow up of 8 months at the recommended...
Read moreFDA Approves Two Hepatitis C Drugs - Sovaldi and Harvoni - for Pediatric Patients
Posted 19 weeks ago in Pharma Industry News
April 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 previously approved to treat HCV in adults. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Direct-acting antiviral drugs reduce the amount of HCV in the body by preventing the virus from...
Read moreFDA Allows Marketing of First Direct-to-Consumer Tests that Provide Genetic Risk Information for Certain Conditions
Posted 19 weeks ago in Pharma Industry News
April 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 that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional. “Consumers can now have ...
Read moreFDA Alerts Consumers of Nationwide Voluntary Recall of EpiPen and EpiPen Jr
Posted 20 weeks ago in Pharma Industry News
March 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 treatment of severe allergic reactions. This recall is due to the potential that these devices may contain a defective part that may result in the devices’ failure to activate. The recalled product was manufactured by Meridian Medical Technologies and distr...
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