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Lawmakers seek to curb skyrocketing generic drug prices

May 27, 2015 9:19 am | News | Comments

Two prominent lawmakers are following through on a promise to do something about recent rises in generic drug prices, with identical House and Senate bills that would force generic drugmakers to pay ...

First FDA-approved biosimilar brings hope for CMO growth

May 22, 2015 1:02 pm | by PRNewswire | News | Comments

The FDA's recent approval of Zarxio, the first biosimilar product approved in the United States...

Can generic drug appearance impact patient adherence?

May 22, 2015 12:13 pm | by Lena Freund, FDA | News | Comments

The FDA wants to know how patient perceptions of medications change when pharmacies switch from...

Rhodes Pharmaceuticals' announces launch of daily treatment for ADHD

May 22, 2015 9:59 am | by PRNewswire | News | Comments

Today, Rhodes Pharmaceuticals L.P. announced that Aptensio XR, a once-daily central nervous...

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FDA Cautions About Dose Confusion and Medication Errors

May 21, 2015 10:23 am | News | Comments

The U.S. Food and Drug Administration (FDA) is warning health care professionals about the risk for dosing errors with the antibacterial drug Zerbaxa (ceftolozane and tazobactam) due to confusion about the drug strength displayed on the vial and carton labeling.

Investigational Hep C Drugs Receive Breakthrough Therapy Designation

May 20, 2015 10:20 am | by Business Wire | News | Comments

Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has amended a previously granted Breakthrough Therapy Designation for the investigational daclatasvir and sofosbuvir combination for use in hepatitis C (HCV) patients.

FDA approves new medication to treat schizophrenia

May 20, 2015 10:12 am | by Janssen Pharmaceuticals | News | Comments

There’s a new treatment option for schizophrenia – INVEGA TRINZA (three-month paliperidone palmitate), the first and only schizophrenia medication to be administered just four times a year, providing the longest dosing interval available.

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Eagle Pharmaceuticals Receives Patent for Rapid Infusion Product

May 19, 2015 8:59 am | by Business Wire | Teva Pharmaceuticals Usa | News | Comments

Eagle Pharmaceuticals, Inc. today announced that the United States Patent and Trademark Office (“USPTO”) has granted U.S. Patent No. 9,034,908, which pertains to the use of the bendamustine hydrochloride (HCl) formulation administered in a 50mL bag within ten minutes.

Puma Biotech Stumbles With Breast Cancer Drug

May 15, 2015 11:53 am | by The Associated Press | News | Comments

Treatment results with the breast cancer drug Herceptin, as well as chemotherapy, did improve, but the drug's backers had been hoping to see better results.

Colombian Ban on Anti-Coca Herbicide is Bittersweet

May 14, 2015 11:54 am | by Jacobo Garcia, Associated Press | News | Comments

Colombian President Santos last week decided to halt fumigation in the wake of a report by a research arm of the World Health Organization classifying (anti-coca) glyphosate as a probable carcinogen.

FDA Panel Backs Vertex Combination Pill for Cystic Fibrosis

May 13, 2015 11:23 am | by Matthew Perrone, AP Health Writer | News | Comments

Federal health advisers recommended approval for an experimental combination drug to treat cystic fibrosis, despite unresolved questions about the benefit of one of the pill's two ingredients.

FDA Fast Tracks Sucampo's Cobiprostone

May 11, 2015 10:28 am | by Sucampo Pharmaceuticals | News | Comments

The FDA has granted Fast Track Designation for cobiprostone, a locally acting chloride channel activator for the prevention of oral mucositis.

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FDA Questions Benefit of Cystic Fibrosis Drug From Vertex

May 8, 2015 11:39 am | by Matthew Perrone, AP Health Writer | News | Comments

The Food and Drug Administration said in an online review that the benefit was small and it is unclear if the addition of a second drug ingredient adds to the pill's effectiveness.

Mylan Launches Generic Seasonale Tablets

May 7, 2015 11:50 am | by Mylan N.V. | News | Comments

Mylan N.V. today announced the U.S. launch of Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, which is the generic version of Teva's Seasonale Tablets.

Teva Announces Adrucil Recall

May 5, 2015 11:44 am | News | Comments

Teva announced a voluntary recall of eight lots of Adrucil (fluorouracil injection, USP) 5 g/100 mL (50 mg/mL) due to the potential presence of particulate matter.

Topical Treatment CMO Continues Expansion

May 5, 2015 9:55 am | by Mike Auerbach, Editor-In-Chief | Blogs | Comments

Dow Development Laboratories in California is working to position itself as the "go-to" contract manufacturer for topical product development services.

FDA Approves Spray-On Surgical Sealant

May 1, 2015 10:46 am | by FDA | News | Comments

The FDA today approved Raplixa, the first spray-dried fibrin sealant approved by the agency. It is used to help control bleeding during surgery.

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Vernalis, Tris Pharma Receive FDA Approval for Tuzistra XR

May 1, 2015 10:36 am | by Vernalis | News | Comments

Tuzistra XR is an extended-release oral suspension combination of codeine and chlorpheniramine in treating coughs and upper respiratory allergies.

GW Pharmaceuticals Receives Orphan Drug Designation For Cannabidiol Treatment of Neonatal Hypoxic-Ischemic Encephalopathy

April 24, 2015 11:15 am | by Globe Newswire | News | Comments

There are currently no FDA-approved medicines specifically indicated for NHIE.

Hospira Recalls One Lot Of Bupivacaine HCl Injection

April 24, 2015 11:02 am | by U.S. Food And Drug Administration | News | Comments

Hospira is issuing a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose (NDC: 0409-1162-02, Lot 38-515-DK, Expiry 1FEB2016) due to one confirmed customer complaint of orange and black, visible particles embedded and free floating within a single-dose glass teartop vial.

Capricor Granted FDA Orphan Drug Designation For Allogeneic Cardiosphere-Derived Cells

April 22, 2015 11:28 am | News | Comments

Capricor Therapeutics, Inc. today announced that it has been granted orphan drug designation by FDA for its cell therapeutic product candidate, CAP-1002, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD).

Glaxo Recalls Flu Vaccine Due to Potency Problem

April 17, 2015 3:37 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The company alerted U.S. customers Tuesday that the vaccine can lose potency and fail to adequately protect against some strains of the flu.

Survey: More Than Half of Older Adults in The US Now Taking Aspirin

April 17, 2015 3:05 pm | by Oregon State University | News | Comments

More than half of the older adults in the United States are now taking a daily dose of aspirin, even though its use is not recommended by the Food and Drug Administration for most people who have not yet had a heart attack or stroke.

FDA Approves First Generic To Treat MS

April 17, 2015 12:16 pm | by FDA | News | Comments

The U.S. Food and Drug Administration today approved the first generic version of Copaxone (glatiramer acetate injection), used to treat patients with relapsing forms of multiple sclerosis (MS).

U.S. Marshals Seize Unapproved Drugs From Florida Distributor

April 16, 2015 3:31 pm | by FDA.gov | News | Comments

Stratus Pharmaceuticals marketed and distributed unapproved prescription drug products that were manufactured by Sonar Products, Inc., of Carlstadt, New Jersey.

OriGen Biomedical Issues Nationwide Recall

April 16, 2015 11:20 am | by OriGen Biomedical | News | Comments

OriGen Biomedical initiated a nationwide recall for one lot of Reinforced Dual Lumen ECMO catheters.

FDA Warns of Liver Injury From Muscle-Building Supplement

April 14, 2015 2:05 pm | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Food and Drug Administration is warning consumers to avoid dietary supplements sold by a Las Vegas company because they may contain anabolic steroids that can cause liver damage.

FDA Confirms Change of Ownership of 23 US Generic Drugs

April 13, 2015 3:54 pm | by PR Newswire | News | Comments

IDT Australia Limited announced that the U.S. Food and Drug Administration (FDA) has confirmed receipt of the change of ownership letters formally transferring ownership of the 23 generic drug products to IDT.

Big Retailers Pull Sales of Weight-Loss Supplements With Dangerous Chemical

April 10, 2015 3:30 pm | by Meagan Parrish, Editor, Chem.Info | News | Comments

The issue also intensified criticisms of the FDA.

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