Patients could soon see an influx of cheaper generic medication onto the market following the US Food and Drug Administration's (FDA) unveiling of new steps to stimulate drug competition and improve access to generic drugs. It published a list of branded off-patent medication currently...
Read More... Jun 26, 2017Prescription & Medication Blog - FDA
Overview
Before any medication appears in U.S. pharmacies, it must first gain approval from the U.S. Food and Drug Administration (FDA). The FDA regulates all drugs and medical devices to ensure their safety and efficacy - this includes all over-the-counter medicine and prescription drugs, which have to pass through a rigorous approval process before being used in the the U.S..
These articles and resources include information on some of the latest and most notable new approvals by the FDA. New approvals sometimes mean exciting new treatments become available to help manage, treat or cure health conditions, or new options appearing for those already undergoing treatment.
As well as regulating the approval of new branded medicines, the FDA is also responsible for the approval process for new generic medications. Around 9 out of 10 prescriptions filled in the U.S. are generic medications, yet they only account for around 25% of the drug spend! Greater availability of generic drugs means more competitive prices at the pharmacy, cheaper prescriptions for patients and more affordable medication.
Find out more about:
- New treatments and approvals
- New generic alternative to expensive branded drugs
- New medical device approvals, such as blood glucose monitors
- Other FDA news and developments
A cheaper alternative to the EpiPen will soon be available in pharmacies for patients suffering from severe allergies. The US Food and Drug Administration (FDA) approved a new epinephrine pre-filled syringe (PFS) called Symjepi, which is manufactured Adamis Pharmaceuticals...
Read More... Jun 19, 2017The US Food & Drug Administration (FDA) has approved the first generic version of Truvada (emitricitabine/tenofovir disoproxil fumarate), a medication used in the treatment and prevention of HIV infection. Gilead Science's branded drug Truvada is a combination of the antiretroviral drugs...
Read More... Jun 15, 2017Endo International is reviewing a request from the US Food & Drug Administration (FDA) to remove the opioid pain medication Opana ER (oxymorphone hydrochloride extended release) from the market. The government body's Drug Safety Risk Management and Anesthetic and Analgesic Drug Products...
Read More... Jun 09, 2017The US Food & Drug Administration (FDA) has approved a generic form of Eli Lilly and Company's Strattera (atomoxetine), used to treat patients with attention-deficit/hyperactivity disorder (ADHD). The generic non-stimulant ADHD medication will be brought to market by Apotex Inc., Teva...
Read More... Jun 06, 2017A topical ocular cetirizine formulation has gained US Food & Drug Administration (FDA) New Drug Application approval for treating allergic conjunctivitis. Zerviate (cetirizine ophthalmic solution 0.24%) was developed by ophthalmic research and development company Nicox. The new topical...
Read More... Jun 02, 2017Sanofi and Regeneron Pharmaceuticals have gained approval from the US Food & Drug Administration (FDA) for use of Kevzara (sarilumab) for treating patients with rheumatoid arthritis. The prescription medication will be available to patients who do not respond to, or are intolerant, to disease...
Read More... May 23, 2017Patients with hypertension now have a cheaper medication option following the US Food & Drug Administration's approval of generic olmesartan medoxomil and hydrochlorothiazide tablets. Aurobindo Pharma USA's latest addition to pharmacies across the country was previously only available as...
Read More... May 16, 2017Non-small cell lung cancer (NSCLC) patients have a new treatment available following the US Food & Drug Administration's (FDA's) approval of Alunbrig (brigatinib). The Takeda Pharmaceuticals medication received Accelerated Approval for treatment of patients with anapestic lymphoma...
Read More... May 16, 2017The US Food & Drug Administration (FDA) has approved the first new treatment for patients with amyotrophic lateral sclerosis (ALS) in 22 years. FDA approval for Radicava (edaravone) was granted following a six-month trial in Japan in which patients given the drug exhibited a slower rate of...
Read More... May 10, 2017A generic version of the cholesterol-lowering medication Vytorin has been launched by Teva Pharmaceutical Industries, bringing another cheaper statin medication to US pharmacies. Vytorin is an HMG-COA reductase inhibitor/statin with a lipid modifying agent developed by Merck. IMS data from...
Read More... May 08, 2017The US Food & Drug Administration (FDA) has approved the drug Stivarga (regorafinib) for treatment of hepatocellular carcinoma (HCC) or liver cancer. It is the first FDA-approved treatment for this condition in nearly a decade. Developed by Bayer HealthCare Pharmaceuticals, Stivarga is already...
Read More... May 01, 2017A new formulation of the opioid oxycodone has been approved by the US Food & Drug Administration (FDA), providing doctors with a new option for treating patients in pain. RoxyBond (oxycodone hydrochloride) is the first immediate-release opioid analgesic with labeling for abuse-deterrent...
Read More... Apr 27, 2017New restrictions on use of certain cough and pain medicine to treat children have been announced by the U.S. Food & Drug Administration (FDA). The government body warned parents and health care professionals that medicines containing codeine and tramadol carry "serious risks" to children under...
Read More... Apr 24, 2017The difficulties treating and diagnosing irritable bowel syndrome (IBS) have been highlighted by the US Food & Drug Administration (FDA). IBS is believed to affect around 20 percent of the population, although many remain unaware they suffer from the gastrointestinal disorder, attributing it to...
Read More... Apr 19, 2017Two medications for treating the hepatitis C virus (HCV) have been granted US Food & Drug Administration (FDA) approval for use on children. Sovaldi (sofosbuvir) and Harvoni (ledipasivir and sofosbuvir) are already prescribed to adults but are the first HCV medications given approval for...
Read More... Apr 11, 2017A new drug to treat adult patients suffering from primary progressive multiple sclerosis (PPMS) has been approved by the US Food & Drug Administration (FDA). Ocrevus (ocrelizumab) was developed by Genentech - a member of the Roche Group - and will be available to patients across the United...
Read More... Apr 04, 2017