Arriving home with a new baby is one of those special life events that new moms will always remember but it can also be an overwhelming and turbulent time. Consequently, it may be unsurprising that up to eight out of ten new mothers experience the “baby blues," a common phenomenon...
Read More... Apr 15, 2019Prescription & 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
If you suffer from the eye disease neurotrophic keratitis, your doctor may soon consider prescribing the topical eye drop Oxervate (cenegermin). It is the first drug approved by the US Food and Drug Administration (FDA) as a treatment for the rare condition. The drug, developed by Italian...
Read More... Sep 03, 2018The US Food and Drug Administration (FDA) has released the first of two new pieces of draft guidance that may eventually enable e-cigarette manufacturers to apply for regulated drug status for their products. FDA Commissioner Scott Gottlieb, MD, said there is “no greater impact we can...
Read More... Aug 06, 2018The US Food and Drug Administration (FDA) has approved Azedra (iobenguane I 131), the first drug approved for treatment of rare unresectable adrenal gland tumors that spread beyond the original tumor site and need treating with a systemic anti-cancer therapy. Adrenal glands, situated above...
Read More... Aug 02, 2018Patients with neutropenia may have improved access to treatment following the US Food and Drug Administration’s (FDA’s) approval of Nivestym (filgrastim-aafi), a biosimilar for Amgen biologic Neupogen (filgrastim). The FDA’s approval of the biosimilar was based on a review...
Read More... Jul 31, 2018Streamlining the process of bringing biosimilars to market is one of the keys to facilitating innovation and reducing healthcare costs, according to US Food and Drug Administration (FDA) Commissioner Scott Gottlieb. Speaking at the Brookings Institution on the release of the FDA’s...
Read More... Jul 29, 2018Last week, Tibsovo (ivosidenib), a new targeted therapy for the treatment of certain adult patients with relapsed or refractory acute myeloid leukemia (AML) with a specific genetic mutation, was approved by the US Food and Drug Administration. Richard Pazdur, MD, director of the FDA’s...
Read More... Jul 25, 2018The US Food and Drug Administration (FDA) is examining ways to empower consumers by improving access to a range of non-prescription and over-the-counter (OTC) medication and drug products. OTC drugs, such as Tylenol (acetaminophen) or Claritin (loratadine), are considered the first line treatment...
Read More... Jul 20, 2018Epidiolex (cannabidiol) is the first medication based on a purified drug substance, cannabidiol (CBD), derived from marijuana to gain approval from the US Food and Drug Administration (FDA). The drug is indicated for patients aged two years and older with Lennox-Gastaut syndrome or Dravet...
Read More... Jul 11, 2018Management of type 1 diabetes in pediatric patients could become easier following the approval of an automated insulin delivery and monitoring system for use in children between the ages of seven and 13. Medtronic’s MiniMed 670G hybrid closed loop system monitors glucose levels and...
Read More... Jul 05, 2018Americans suffering from severe emphysema now have a new treatment option available following the decision by the US Food and Drug Administration (FDA) to approve the Zephyr Endobronchial Valve, or Zephyr Valve. The device, marketed by Pulmonx Inc, is placed into diseased areas of the lungs by a...
Read More... Jul 04, 2018Patients with type 1 or type 2 diabetes now have a new option for monitoring their glucose levels following the US Food and Drug Administration’s (FDA) decision to approve the first continuous glucose monitoring (CGM) system with a fully implantable sensor. The Eversense CGM can be...
Read More... Jul 03, 2018Patients struggling to break dependence on opioids will soon have a cheaper treatment option available following the US Food and Drug Administration’s (FDA) decision to approve the first generic sublingual version of Suboxone (buprenorphine and naloxone). In April 2017, the US...
Read More... Jul 02, 2018A new treatment option will soon be available for children aged five and over with asthma following the US Food and Drug Administration’s (FDA) decision to expand its approval of the GlaxoSmithKline (GSK) Arnuity Ellipta (fluticasone furoate) inhaler. The medication was first approved...
Read More... May 25, 2018A “novel” new preventative treatment for migraines in adults, which works by blocking the activity of a molecule involved in migraine attacks, has been approved by the US Food and Drug Administration (FDA). Approval for Aimovig (erenumab-aooe) was granted to Amgen Inc following three...
Read More... May 21, 2018The US Food and Drug Administration (FDA) has granted approval to Gilenya (fingolimod) as a treatment for children and adolescents with multiple sclerosis (MS). The Novartis medication is the first drug approved by the FDA for treatment of pediatric patients with MS. Gilenya first gained FDA...
Read More... May 18, 2018Patients with anemia caused by chronic kidney disease, chemotherapy, or those with HIV who take Retrovir (zidovudine) will soon have a new medication option in the form of Retacrit (epoetin alfa-epbx). The drug is the first biosimilar for epoetin-alfa to gain US Food and Drug Administration (FDA)...
Read More... May 18, 2018The US Food and Drug Administration (FDA) has approved the protein kinase inhibitor Tagrisso (osimertinib) as a first-line treatment option for certain patients with metastatic non-small cell lung carcinoma (NSCLC). Earlier this month, AstraZeneca presented new data from a Phase III FLAURA trial...
Read More... Apr 24, 2018The US Food and Drug Administration (FDA) has approved Crysvita (burosumab) as a treatment for a rare form of inherited rickets. It is the first drug therapy approved as a treatment for x-linked hypophosphatemia (XLH) with evidence of bone disease in children over one year of age and adolescents...
Read More... Apr 18, 2018The US Food and Drug Administration (FDA) has permitted marketing of a medical device that utilizes artificial intelligence (AI) to detect certain eye problems related to diabetes. It is the first device of its kind to harness AI to detect diabetic retinopathy considered greater than a mild level...
Read More... Apr 16, 2018