www.dailyrx.com - FDA Drug Approvals

FDA Approves Gleevec for Rare Gastrointestinal Cancer

Staff — Wed, 01 Feb 2012 15:09:34 +0000

The U.S. Food and Drug Administration granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today’s action also highlights an increase in overall patient survival when the drug is taken for 36 months rather than the standard 12 months of treatment.

FDA Approved New Type 2 Diabetes Drug

Staff — Tue, 31 Jan 2012 19:50:41 +0000

Boehringer Ingelheim Pharmaceuticals, Inc. and Eli Lilly and Company today announced the U.S. Food and Drug Administration (FDA) has approved Jentadueto (linagliptin/metformin hydrochloride) tablets, a new tablet combining the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin.

Bydureon Approved for Type Two Diabetes

Travis Hill — Mon, 30 Jan 2012 22:36:03 +0000

Some diabetes drugs have to be taken multiple times a day. For many patients, it can be hard to stay on such a strict schedule. Now, patients have the option of a once-weekly drug for type 2 diabetes.

FDA Approves Advanced Basal Cell Cancer Drug

Staff — Mon, 30 Jan 2012 18:18:19 +0000

Roche announced that Erivedge (vismodegib) capsule was approved by the U.S. Food and Drug Administration (FDA) for adults with a type of skin cancer, called basal cell carcinoma (BCC), that has spread to other parts of the body or that has come back after surgery or that their healthcare provider decides cannot be treated with surgery or radiation.

FDA Approves Inlyta to Treat Patients With a Type of Advanced Kidney Cancer

Staff — Fri, 27 Jan 2012 19:46:45 +0000

The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer.

Voraxaze Approved To Treat Toxic Methotrexate Levels

Staff — Wed, 18 Jan 2012 19:45:07 +0000

The U.S. Food and Drug Administration approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure.

Prevnar 13 Approved for New Age Category

Staff — Tue, 03 Jan 2012 17:04:24 +0000

Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae) serotypes contained in the vaccine.

Helping Kids Awaiting Heart Transplant

Deanna Morey — Sun, 25 Dec 2011 02:36:10 +0000

U.S. Food and Drug Administration officials have given the green light to a device designed to support weakened hearts in children with heart failure who are awaiting a transplant.

FDA Approves Combo Hypertension Treatment

Deanna Morey — Thu, 22 Dec 2011 00:11:03 +0000

U.S. Food and Drug Administration officials have approved new combination hypertension drug Edarbyclor, which combines azilsartan medoxomil and chlorthalidone.

FDA Approves Insomnia Drug Intermezzo

Staff — Wed, 23 Nov 2011 19:59:04 +0000

The U.S. Food and Drug Administration today approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

FDA Approves Eylea For Eye Disorder In Older People

Staff — Mon, 21 Nov 2011 15:51:06 +0000

The U.S. Food and Drug Administration today approved Eylea (aflibercept) to treat patients with wet (neovascular) age-related macular degeneration (AMD), a leading cause of vision loss and blindness in Americans ages 60 and older.

Erwinaze Approved to Treat Leukemia

Laurie Stoneham — Sat, 19 Nov 2011 08:37:41 +0000

The U.S. Food and Drug Administration has approved Erwinaze (asparaginase Erwinia chrysanthemi) to treat patients with acute lymphoblastic leukemia (ALL), who have developed an allergy (hypersensitivity) to E. coli derived asparaginase and pegapargase chemotherapy drugs used to treat ALL.

FDA Approves First Drug to Treat a Rare Bone Marrow Disease

Staff — Wed, 16 Nov 2011 21:06:19 +0000

The U.S. Food and Drug Administration today approved Jakafi (ruxolitinib), the first drug approved to specifically treat patients with the bone marrow disease myelofibrosis.

Frequently Asked Questions about the FDA Drug Approval Process

Staff — Tue, 15 Nov 2011 18:35:49 +0000

Q: Why are drugs evaluated by the FDA?

A: Drugs intended for human use are evaluated by FDA’s Center for Drug Evaluation and Research (CDER) to ensure that drugs marketed in the United States are safe and effective. Biological products are evaluated by FDA’s Center for Biologics Evaluation and Research.

Q: Does FDA test drugs?

FDA approves Erbitux to treat late-stage head and neck cancer

Staff — Mon, 14 Nov 2011 14:41:21 +0000

The U.S. Food and Drug Administration today approved Erbitux (cetuximab) for use with chemotherapy to treat patients with late-stage (metastatic) head and neck cancer.

First Cord Blood Product Gets FDA Stamp of Approval

Deanna Morey — Sun, 13 Nov 2011 00:51:44 +0000

For the first time, U.S. Food and Drug Administration officials have given the green light to an umbilical cord blood product that could be used in stem cell transplants for patients with blood cancer and metabolic or immune disorders.

FDA Approves Exparel For Postsurgical Pain Management

Staff — Mon, 31 Oct 2011 15:39:13 +0000

Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved EXPAREL(TM) (bupivacaine liposome injectable suspension) 1.3% for administration into the surgical site to produce postsurgical analgesia.

FDA approves Ferriprox

Staff — Tue, 25 Oct 2011 14:48:01 +0000

The U.S. Food and Drug Administration today approved Ferriprox (deferiprone) to treat patients with iron overload due to blood transfusions in patients with thalassemia, a genetic blood disorder that causes anemia, who had an inadequate response to prior chelation therapy.

FDA approves Onfi to treat severe type of seizures

Staff — Mon, 24 Oct 2011 21:43:21 +0000

On Oct. 21, the U.S. Food and Drug Administration approved Onfi tablets (clobazam) for use as an adjunctive (add-on) treatment for seizures associated with Lennox-Gastaut syndrome in adults and children 2 years of age and older.

FDA Rejects Expanded Designation for Parkinson's Treatment

Deanna Morey — Wed, 19 Oct 2011 11:43:03 +0000

A U.S. Food and Drug Administration panel has unanimously voted to reject an expanded indication for Parkinson's drug rasagiline (Azilect).

FDA Panel Green Lights New PAD Stent

Deanna Morey — Fri, 14 Oct 2011 13:45:34 +0000

A U.S. Food and Drug Administration panel has unanimously voted to approve the first drug-eluting stent developed to treat peripheral artery disease after deeming it both effective and safe.

New Drug Treats Diabetes and High Cholesterol

Sarah Naseem Walker — Sun, 09 Oct 2011 17:19:29 +0000

The FDA has approved Juvisync, a prescription medication that contains two previously approved medicines in one tablet: Januvia (sitagliptin) for diabetes and Zocor (simvastatin) for high cholesterol.

FDA Approves Soliris For Rare Pediatric Blood Disorder

Joseph V. Madia, MD — Thu, 29 Sep 2011 19:30:52 +0000

The U.S. Food and Drug Administration today approved Soliris (eculizumab) to treat patients with atypical Hemolytic Uremic Syndrome (aHUS), a rare and chronic blood disease that can lead to kidney (renal) failure and is also associated with increased risk of death and stroke.

Melanoma Detection Device Gaining Approval

Laurie Stoneham — Tue, 27 Sep 2011 15:59:17 +0000

Dermatologists have no true test for determining if a skin lesion may be melanoma, the deadliest form of skin cancer. A new tool is gaining approval that will give physicians more reliable information to detect the disease when it's most curable.

Advanced Prostate Cancer Breakthrough?

Laurie Stoneham — Tue, 27 Sep 2011 14:03:25 +0000

The treatment options for advanced prostate cancer that's spread to the bone are minimal at this point. An experimental drug that's currently being tested may soon change the outlook for patients.

FDA Approves Prolia for osteoporosis

Staff — Mon, 19 Sep 2011 19:17:22 +0000

On September 16, 2011, the U.S. Food and Drug Administration granted approval for denosumab (Prolia, Amgen Inc.) as a treatment to increase bone mass in patients at high risk for fracture receiving androgen deprivation therapy (ADT) for nonmetastatic prostate cancer or adjuvant aromatase inhibitor (AI) therapy for breast cancer. In men with nonmetastatic prostate cancer, denosumab also reduced the incidence of vertebral fracture.

Ovarian Cancer in Pelvic Masses

Laurie Stoneham — Fri, 09 Sep 2011 16:00:05 +0000

A mass in your pelvis is detected. Scary. Now you and your doctors obviously want to know if it's cancer. That's been difficult to determine - before now.

FDA Committee Backs Heart Arrhythmia Drug

Deanna Morey — Fri, 09 Sep 2011 12:59:37 +0000

In a what came as a surprise move to many, the U.S. Food and Drug Administration advisory committee today voted to recommend heart arrhythmia drug rivaroxiban (Xarelto) for approval.

FDA Panel Warns Against Approval of Heart Arrhythmia Drug

Deanna Morey — Wed, 07 Sep 2011 16:50:56 +0000

U.S. Food and Drug Administration reviewers have warned against immediate approval of rivaroxaban (Xarelto) and questioned effectiveness of the medication for preventing stroke in high-risk atrial fibrillation patients.

New Test Detects Treatable Lung Cancer Gene

Laurie Stoneham — Sat, 03 Sep 2011 18:20:05 +0000

Days after receiving U.S. Food and Drug Administration (FDA) approval, the Abbott ALK test for non-small-cell lung cancer (NSCLC) has become available in the United States, European Union and New Zealand.