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Spark Therapeutics Appoints Former Chief of FDA’s Gene Therapy Branch as Head of Regulatory Affairs

November 25, 2014 2:06 pm | News | Comments

Spark Therapeutics has announced today appointment of Daniel M. Takefman, Ph.D., as head of regulatory affairs. Dr. Takefman previously served as chief of the gene therapy branch of the Center for Biologics Evaluation and Research at the FDA, a position he held since 2006.

Mylan Files Patent Challenge Relating to BREVIBLOC(R)

November 25, 2014 11:07 am | News | Comments

Mylan has confirmed that it and several subsidiaries have been sued by several Baxter...

FDA Approves Valeant’s ONEXTON Acne Gel

November 25, 2014 8:13 am | News | Comments

Valeant Pharmaceuticals has received approval from the FDA for ONEXTON Gel (clindamycin...

New FDA Rules Will Put Calorie Counts on Menus

November 25, 2014 8:01 am | by MARY CLARE JALONICK, Associated Press | News | Comments

Whether they want to or not, consumers will soon know how many calories they are eating when...

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FDA Grants Priority Review to Two Bayer Respiratory Meds

November 25, 2014 7:51 am | by The Associated Press | News | Comments

Two medicines Bayer HealthCare Pharmaceuticals Inc. is testing for respiratory disorders will get priority review by U.S. regulators and other benefits under a 2012 program to boost development of new antibiotics.      

Aurobindo Pharma Recalls Northstar Label Gabapentin Capsules, USP 300 mg Due to Complaints of Empty Capsules

November 24, 2014 3:04 pm | News | Comments

Aurobindo Pharma USA is voluntarily recalling lot GESB14011-A of Gabapentin Capsules, USP 300 mg 100-count bottles to the consumer level. The product lot has been found to contain some empty capsules.         

FDA Issues Additional Guidance for Outsourcing Facilities That Compound Sterile Human Drugs

November 24, 2014 1:18 pm | News | Comments

The FDA has issued three additional policy documents to assist entities that compound sterile human drugs with registering as outsourcing facilities. The policy documents will also assist entities with complying with provisions of the DQSA, which was enacted in November 2013.

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FDA Strengthens Warning on Device Linked to Cancer

November 24, 2014 11:50 am | by LINDA A. JOHNSON, AP Business Writer | News | Comments

The FDA is taking immediate steps to help reduce the risk of spreading unsuspected cancer in women being treated for uterine fibroids. In an updated safety communication, originally issued in April 2014, the FDA warns against using laparoscopic power morcellators in the removal of the uterus (hysterectomy) or fibroids (myomectomy) in the vast majority of women.

FDA Approves Hard-to-Abuse Hydrocodone Pill

November 20, 2014 3:27 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Federal health regulators have approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking such safeguards.       

Soaring Generic Drug Prices Draw Senate Scrutiny

November 20, 2014 8:35 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington lawmakers.     

Dupilumab Receives FDA Breakthrough Therapy Designation in Atopic Dermatitis

November 20, 2014 8:09 am | News | Comments

Regeneron Pharmaceuticals and Sanofi have announced that the FDA has granted Breakthrough Therapy designation to dupilumab for the treatment of adults with moderate-to-severe atopic dermatitis (AD) who are not adequately controlled with topical prescription therapy and/or for whom these treatments are not appropriate.

The Fight to Get Female Viagra on the Market

November 18, 2014 8:56 am | Videos | Comments

Cindy Whitehead is trying to get Flibanserin, the first low libido drug for women, approved by the FDA.                         

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Heart Stents May Require Longer Blood Thinner Use

November 18, 2014 8:37 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

Millions of people with stents that prop open clogged heart arteries may need anti-clotting drugs much longer than the one year doctors recommend now. A large study found that continuing for another 18 months lowers the risk of heart attacks, clots and other problems.

Study Lifts Cloud Over Heart Drugs Zetia, Vytorin

November 18, 2014 8:31 am | by MARILYNN MARCHIONE, AP Chief Medical Writer | News | Comments

A major study lifts a cloud around Zetia and Vytorin, blockbuster drugs for lowering cholesterol. The study found that these pills modestly lower the risk of heart attacks and other problems in people at high risk for them — evidence that's been missing for more than a decade as the drugs racked up billions in sales.

Lemtrada Approved for Multiple Sclerosis

November 17, 2014 8:18 am | News | Comments

The U.S. Food and Drug Administration has approved Lemtrada, a treatment for relapsing multiple sclerosis made by the drugmaker Genzyme. The drug has already been approved by the European Medicines Agency for use in the European Union and in Canada and Australia.

FDA Approves Janssen’s Schizoaffective Disorder Treatment

November 13, 2014 1:53 pm | News | Comments

Janssen Pharmaceuticals has announced that the FDA approved the supplemental New Drug Applications (sNDAs) for the once-monthly atypical long-acting antipsychotic INVEGA SUSTENNA (paliperidone palmitate) to treat schizoaffective disorder as either monotherapy or adjunctive therapy.

Pharmaceutical Processing’s Nov/Dec 2014 Digital Issue

November 13, 2014 11:13 am | Digital Editions | Comments

Pharmaceutical Processing’s Nov/Dec 2014 issue features an in-depth look at SAFC’s recently expanded high-potency API manufacturing facilities in Madison, WI. In addition, our Annual CMO/CSO Survey is included in this issue detailing the trends driving the CMO/CSO market. Other articles take a look at elastomeric closure in parenteral manufacturing, cleanroom energy efficiency, package integrity, deduster design efficiency, and desiccant canister design and feeding options.

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Mallinckrodt Responds to FDA’s Reclassification of Methylphenidate ER

November 13, 2014 8:12 am | News | Comments

Mallinckrodt has been informed by the FDA that the agency has reason to believe that the company’s methylphenidate hydrochloride extended-release (ER) tablets, USP (CII) may not be therapeutically equivalent to the category reference drug Concerta®.

Ebola Drug Testing Sparks Ethics Debate

November 12, 2014 2:22 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

Health officials are scrambling to begin human testing of a handful of experimental drugs for Ebola. But the effort has sparked an ethical debate over how to study unproven medicines amid an outbreak that has killed nearly 5,000.    

FDA Approves Par Pharmaceutical’s Vasostrict Injection

November 12, 2014 8:08 am | News | Comments

Par Pharmaceutical Companieshas received approval for its New Drug Application (NDA) for Vasostrict (vasopressin injection, USP) 20 units/mL from the U.S. Food and Drug Administration (FDA) pursuant to section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

Orexigen Rises as Weight Loss Drug Review Proceeds

November 10, 2014 2:24 pm | News | Comments

Shares of Orexigen Therapeutics jumped Monday after the company said a European Union review of its weight loss drug Contrave, which was approved in the U.S. in September, is progressing on schedule.         

FDA Cracking Down on Dietary Supplement Company

November 10, 2014 8:54 am | Videos | Comments

The Food and Drug Administration is suing one company for allegedly failing to properly test its ingredients.                        

FDA Approves Ipsen's New Delivery Device for Somatuline® Depot® (lanreotide) Injection

November 6, 2014 11:44 am | News | Comments

Ipsen Biopharmaceuticals announced that the FDA has approved a new device to deliver Somatuline® Depot® (lanreotide). The device has an enhanced, prefilled, low-volume syringe that supports full-dose delivery with no reconstitution requirements.

FDA Approves Ranbaxy’s Fenofibrate Capsules

November 6, 2014 8:43 am | News | Comments

Ranbaxy Labs has received approval from the FDA to manufacture and market Fenofibrate Capsules USP, 43 mg and 130 mg. The FDA has determined the Ranbaxy formulations to be bioequivalent and have the same therapeutic effect as that of the reference listed drug Antara Capsules, 43 and 130 mg, respectively.

FDA Selects ICON to Develop New Patient-Reported Outcome Measure for Hospital-Acquired Bacterial Pneumonia Trials

November 6, 2014 8:29 am | News | Comments

ICON has been awarded a project by the FDA to develop an industry-standard Patient Reported Outcome (PRO) measure that can be used in anti-bacterial drug development trials for hospital-acquired bacterial pneumonia (HABP).     

FDA Issues Complete Response Letter for Aeterna Zentaris' Macrilen NDA

November 6, 2014 8:13 am | News | Comments

Aeterna Zentaris announced that the company has received a Complete Response Letter (CRL) from the FDA for its New Drug Application for Macrilen, a novel orally-active ghrelin agonist, for use in evaluating adult growth hormone deficiency. Based on its review, the FDA has determined that the NDA cannot be approved in its present form.

US Officials Unveil Plan to Test Ebola Drugs

November 5, 2014 4:07 pm | by Marilynn Marchione - AP Chief Medical Writer - Associated Press | News | Comments

The quest for an Ebola treatment is picking up speed. Federal officials have unveiled a plan to test multiple drugs at once, in an umbrella study with a single comparison group to give fast answers on what works. "This is novel for us" and is an approach pioneered by cancer researchers, said Dr....

Company Formed from University of Missouri Research Makes First Product

November 2, 2014 6:33 pm | News | Comments

Nanova Biomaterials began manufacturing a fluoride dental varnish called StarBright about a month ago after the product received approval from the Food and Drug Administration.             

FDA Advisory Committee Makes Recommendation to Approve Daiichi Sankyo's SAVAYSAT

October 31, 2014 8:28 am | News | Comments

Daiichi Sankyo announced that the FDA's Cardiovascular and Renal Drugs Advisory Committee voted 9 to 1 to recommend approval of once-daily SAVAYSAT 60 mg dosing regimen for the reduction in risk of stroke and systemic embolic events in patients with non-valvular atrial fibrillation.

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