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Agency Actions

Empagliflozin/Linagliptin Tablet Submitted for FDA Review for Treatment of Type-2 Diabetes in Adults

Filing follows completion of phase III trial

Parkinson’s Drug Rytary (Carbidopa/Levodopa) Resubmitted for FDA Review

Company provides updated safety and stability data

New Drug Application Submitted to FDA for Fixed-Dose Atazanavir/Cobicistat Combo for HIV-1 Patients

Treatment eliminates need for boosting agent in separate tablet

Mydicar Receives ‘Breakthrough Therapy’ Designation as Heart Failure Treatment

Cardiac catheter delivers gene therapy directly to heart

FDA Halts Mid-Stage Study of Recombinant Hyaluronidase in Pancreatic Cancer

Thromboembolic events raise concerns

Supplemental New Drug Application Filed for Ibrutinib (Imbruvica) for Treatment of Leukemia and Lymphoma

Treatment improves survival versus ofatumumab

Regulatory Approval Sought for HCV Combo Treatment

Daclatasvir + asunaprevir targets genotype 1b infection

Meningitis B Vaccine Bexsero Receives ‘Breakthrough Therapy’ Designation

FDA submission expected in second quarter of 2014

FDA Delays Decision on Inhaled Insulin Product Afrezza

Advisory panel recommended approval

Janssen Seeks Approval for Combination HIV Therapy

Darunavir and cobicistat tablet would eliminate need for separate boosting agent

FDA Advisors Back Two Antibiotics for ABSSSIs

Anti-Infective Drugs Advisory Committee votes unanimously for Dalvance and Sivextro

FDA Panel Recommends Approval of DNA-Based Colon Cancer Test

Testing demonstrates 92% sensitivity

FDA Advisors Question Safety and Effectiveness of Diabetes Device, Afrezza

Deficiencies include potential effects on lung function

Eye Treatment Iluvien (Fluocinolone Intravitreal Implant) Tries Again for FDA Approval

Drug–device combo rejected in October 2013

FDA Agrees to Review Drug–Device Combo for Migraine

Approval decision expected in November

FDA Committee Gives ‘Thumbs Down’ to Serelaxin for Acute Heart Failure

Advisors question efficacy data

FDA Halts Patient Enrollment in Myelofibrosis Trial

Agency cites potential for hepatotoxicity with imetelstat

FDA Postpones Decision on MS Drug Plegridy

Agency needs more time to review application

Xtandi (Enzalutamide) Submitted to FDA for Expanded Labeling

Approval sought for use in chemo-naïve patients with advanced prostate cancer

FDA Halts Testing of Cancer Drug Imetelstat

Agency cites risk of liver toxicity

FDA Gives Green Light to Studies of Extended-Release Metadoxine in Adults With ADHD

Phase III trial to begin enrollment in first quarter of 2014

FDA Rejects Empagliflozin for Type 2 Diabetes

Agency cites manufacturing deficiencies

FDA Grants ‘Fast Track’ Designation to Antibiotic Cadazolid for Treatment of Diarrhea

Phase III studies compare cadazolid and vancomycin (February 27)

Promacta (Eltrombopag) Submitted to FDA for Treatment of Severe Aplastic Anemia

Drug is currently approved for thrombocytopenia (February 28)

FDA Accepts New Drug Application for Antiviral Agent Peramivir

Approval decision scheduled for December (February 25)

FDA Will Review Eylea (Aflibercept) for Treatment of Macular Edema Following Retinal Vein Occlusion

Approval decision expected in October (February 24)

Daclatasvir/Asunaprevir Combo Receives ‘Breakthrough Therapy’ Designation for Hepatitis C

Treatment targets genotype 1b HCV (February 24)

FDA Agrees to Review 9-Valent HPV Vaccine

Vaccinations prevent precancers in phase III study (February 20)

FDA Seeks to Modernize OTC Drug Reviews

Forty-year-old system needs overhaul (February 21)

Proposed Asthma Inhaler Puts Patients at Risk, Group Says

FDA panels will meet on February 25 (February 19)

FDA Grants ‘Fast Track’ Designation to Extended-Release Morphine and Oxycodone

Abuse-deterrent formulations target moderate-to-severe pain (February 20)

FDA Grants Priority Review to Intravenous Antibiotic Oritavancin

Approval decision expected in August 2014 (February 19)

Illegal Drug Sellers Nabbed for Smuggling Bogus Cancer Drugs Into U.S.

FDA leads international crackdown (February 13)

FDA Rejects Expanded Indications for Anticoagulant Drug Xarelto (Rivaroxiban)

Agency advisors questioned clinical trial data (February 14)

FDA Rejects Depot Bupivacaine (Posidur) for Postoperative Pain Relief

Agency asks for additional safety studies (February 12)

FDA Panel Says Data Do Not Support Lower Cardiac Risk of Naproxen

Labeling remains unchanged for now (February 11)

FDA Reviews Heart Failure Risk With Diabetes Drug Saxagliptin (Onglyza)

NEJM study prompts request for trial data (February 11)

FDA Expands Ibrutinib (Imbruvica) Label to Include Chronic Lymphocytic Leukemia

Treatment already approved for mantle cell lymphoma (February 12)

New Drug Application Filed for Ledipasvir/Sofosbuvir Combo Tablet for Hepatitis C

Treatment targets gentotype-1 HCV (February 10)

FDA Asks for More Trials of Female Libido Treatment

Agency rejected flibanserin last year (February 11)

FDA Committee Issues Mixed Opinions on Blood Clot Drug Cangrelor

Team leader recommends against approval (February 10)

FDA Grants Fast Track Designation to Huntington's Disease Treatment

PDE10 inhibitor enters phase II study (February 5)

FDA Rejects Oral Film for Acute Migraines

Rizatriptan formulation constricts blood vessels in the brain (February 4)

New Drug Application Submitted for Migraine Treatment

Intranasal delivery system uses sumatriptan powder (January 30)

FDA Agrees to Review Budesonide Foam for Patients With Ulcerative Colitis

Approval decision slated for September 2014 (January 30)

FDA Panel: Allergy Treatment Ragwitek Is Safe and Effective

Sublingual pill offers alternative to injections (January 24)

Validive (Clonidine Lauriad) Receives ‘Fast Track’ Designation for Prevention and Treatment of Oral Mucositis Induced by Anticancer Treatments

Mucoadhesive tablet delivers clonidine in the mouth (January 23)

FDA Agrees to Review Updated Prescribing Information for Stendra (Avanafil)

Approval decision scheduled for September 2014 (January 21)

FDA Rejects Expanded Labeling for Feraheme (Ferumoxytol)

Drug fails to win anemia indication (January 22)

FDA Rejects Vascepa (Icosapent Ethyl) Trial Design

Company plans to appeal decision (January 21)

FDA Issues Statement on IV Fluid Shortage

Agency is working with manufacturers to fix the problem (January 17)

Surgeon General Adds to List of Smoking’s Harms

Report finds cigarette smoking linked to diabetes and colorectal cancer (January 17)

Human Infection With Avian Influenza A (H5N1) Virus

First case reported in North America (January 15)

FDA Limits Acetaminophen in Prescription Combination Products

Agency caps maximum at 325 mg to reduce risk of liver toxicity (January 14)

FDA Advisory Panel Recommends Approval of Hypotension Drug Northera (Droxidopa)

Approval decision expected in February (January 14)

FDA Agrees to Review Zorvolex (Diclofenac) for OA Pain in Adults

First lower-dose NSAID using fine-particle technology (January 15)

FDA Advisors Doubt Efficacy of Xarelto (Rivaroxiban) in Reducing Heart Risk

Pivotal efficacy data questioned (January 14)

Tafinlar (Debrafenib) Receives FDA ‘Breakthrough’ Designation for Lung Cancer

Drug is currently approved for melanoma (January 13)

FDA Advisors Recommend Approval of Anti-Clot Drug Vorapaxar

Global trial provides supportive data (January 13)

FDA Panel Questions Long-Term Efficacy of Blood Pressure Drug Droxidopa

Treatment lacks evidence of durability, reviewers say (January 10)

FDA Agrees to Review Weight-Loss Drug Contrave (Naltrexone/Bupropion)

Approval decision expected in June 2014 (January 7)

FDA Recalls Parenteral Nutrition Products Clinimix and Clinimix E

Agency cites complaints of particulate matter (January 6)

FDA Lifts Hold on Studies of Cancer Drug Tosedostat

Agency requested data on heart-related events (January 2)

New Drug Application Submitted for Once-Daily Tacrolimus (Envarsus) in Kidney Transplant Recipients

Immunosuppressive treatment helps prevent graft rejection (December 30)

FDA Rejects Lemtrada (Alemtuzumab) for Treatment of Multiple Sclerosis

Benefits don’t outweigh risks (December 30)

FDA Agrees to Review New Insulin Glargine Product

NDA filed for long-acting insulin (December 20)

Liraglutide Submitted for Regulatory Approval as Obesity Treatment

Drug is indicated for type-2 diabetes as Victoza (December 20)

FDA Delays Decision on Expanded Labeling for Vascepa (Icosapent Ethyl)

Omega-3 product reduces triglyceride levels (December 20)

Company Seeks Eye Treatment Approval for Fourth Time

Intraocular fluocinoline treats diabetic macular edema (December 19)

FDA Agrees to Review Eylea (Aflibercept) for Diabetic Macular Edema

Approval decision expected in August 2014 (December 18)

FDA Issues Proposed Rule for Antibacterial Soaps

Companies must show that their products are better than plain soap and water (December 16)

FDA Advisors Recommend Approval of Dapagliflozin for Type 2 Diabetes

Agency decision expected in January 2014 (December 12)

FDA Panel Backs Anti-Stroke Device

Approval decision expected in first half of 2014 (December 11)

FDA Grants Priority Review to Eliglustat (Cerdelga) for Gaucher Disease

Drug provides oral treatment alternative (December 11)

FDA Advisors Recommend Approval of Bowel Disease Drug Vedolizumab

Experts say benefits outweigh risks (December 9)

FDA Advisors See PML Risk With Colitis Drug Vedolizumab

Risk may be similar to that of natalizumab (December 5)

FDA Issues Safety Communication on Defibrillators

Certain automated external devices don’t deliver needed shock (December 3)

FDA to Review Zalviso (Sublingual Sufentanil) for Treatment of Acute Pain

Hospitalized patients self-dose with handheld system (December 2)

FDA Warns of Serious Skin Reactions With Anti-Seizure Drug Onfi (Clobazam)

Agency approves label changes (December 3)

FDA Extends Review Deadline for Hemophilia Drug Alprolix

Fusion protein delays breakdown of immunoglobulin (December 2)

FDA Agrees to Review Targiniq ER (Oxycodone/Naloxone) for Treatment of Chronic Pain

Drug is marketed in 32 countries (November 26)

FDA Removes Restrictions on Diabetes Drug Rosiglitazone (Avandia)

No evidence for increased risk of heart attack (November 25)

FDA Warns of Risk of Heart Attack, Death With Cardiac Stress-Test Drugs

Agency updates labels for regadenoson and adenosine (November 20)

FDA Rejects Schizophrenia Drug Cariprazine

Agency requests more trial data (November 21)

FDA Panel Backs Approval of Vimizim for Treatment of Rare Genetic Disorder

Committee cites positive phase III data (November 19)

FDA Agrees to Review Naloxegol for Use in Opioid-Induced Constipation

11 to 18 Million Patients Affected (November 19)

FDA Advisors Recommend Approval of Sleep-Disorder Drug, Tasimelteon

Review set for January 2014 (November 12)

FDA Says NDA Filing for Muscular Dystrophy Drug Eteplirsen Is ‘Premature’

Agency raises doubt about clinical trial (November 12)

CDC Warning: Acute Hepatitis and Liver Failure After Use of Dietary Supplement for Weight Loss or Muscle Building

Agency recommends increased vigilance by health care providers (November 8)

FDA Panel Questions Safety of MS Drug Alemtuzumab (Lemtrada)

Announcement casts doubt on approval decision (November 8)

Bleeding in Spinal Column From Enoxaparin Use

Updated information will be added to label (November 6)

FDA Targets Trans Fat in Processed Foods

Heart risks may lead to total ban (November 7)

FDA Agrees to Review Epilepsy Drug Vimpat (Lacosamide) as Monotherapy

Approval would expand label from adjunctive use (November 4)

FDA Outlines Plan to Combat Drug Shortages

More than a hundred medications were hard to find in 2012 (October 31)

Boxed Warning Added to Ezogabine (Potiga) Label

Antiseizure drug has risk of vision loss (October 31)

FDA Agrees to Review Insulin Inhalation Powder, Afrezza

Approval decision slated for April 2014 (October 30)

Sales of Blood Cancer Drug Ponatinib (Iclusig) Suspended

Company responds to FDA request (October 31)

FDA Advisors Recommend Approval of Simeprevir for Treatment of Hepatitis C

Drug would be indicated for adults with liver disease, including cirrhosis (October 24)

FDA to Complete Phase-Out of Chlorofluorocarbon Inhalers

Effort helps protect ozone layer (October 23)

Single-Tablet HIV Regimen Submitted for FDA Review

Treatment combines dolutegravir, abacavir, and lamivudine (October 22)

FDA Grants Priority Review to Ramucirumab as Single-Agent Treatment for Advanced Gastric Cancer

Final approval decision expected in second quarter 2014 (October 23)