June 24, 2015

Aurobindo Pharma Limited has announced that it has received final approval from the U.S. Food and Drug Administration for entacapone tablets USP, 200 mg, the generic equivalent to Comtan Tablets 200 mg.

June 10, 2015

Despite high-profile efforts to implement abuse-deterrent labels and properties on brand-name opioids, advisory company Avalere Health’s latest research notes a key blind spot in the efforts — accessibility.

June 2, 2015
Aurobindo Pharma Limited has received approval from the Food and Drug Administration for its generic equivalent to Flagyl (metronidazole) tablets in 250- and 500-mg dosage strengths.  
 
May 26, 2015

Aurobindo Pharma has submitted an abbreviated new drug application for dolutegravir 50 mg to the Food and Drug Administration for the treatment of HIV.

April 14, 2015

Diplomat Pharmacy announced it will distribute Novartis' new medicine Jadenu, which is indicated to treat patients with chronic iron overload. 

April 1, 2015

Teva said it expects the product to be available to patients during second-quarter 2015.

March 31, 2015

The drug is Food and Drug Administration-approved to treat opioid-induced constipation in adults with chronic, non-cancer pain. 

March 11, 2015

Mylan expanded its portfolio of generic products with the U.S. launch of buprenorphine hydrochloride sublingual tablets in 2-mg and 8-mg strengths, the generic version of Subutex from Reckitt Benckiser.

February 25, 2015

In 10 years, the percentage of opioid analgesic users who used an opioid analgesic stronger than morphine increased from 17% to 37%, NCHS reported Wednesday. 

February 20, 2015

Actavis on Friday gained approval for a generic version of Reckitt Benckiser's Subutex, indicated for the treatment of opioid dependence.

February 3, 2015

Zogenix last week announced that the Food and Drug Administration approved a new formulation of the company's Zohydro ER (hydrocodone bitartrate) extended-release capsules, CII.

January 30, 2015

Janssen Therapeutics on Thursday announced that the Food and Drug Administration has approved its Prezcobix (darunavir 800 mg/cobicistat 150 mg) tablets. The drug is used to treat human immunodeficiency virus in combination with other antiretovirals for treatment-naïve and treatment-experienced adults with no darunavir resistance-associated substitutions, according to the company.

 

January 26, 2015

Purdue Pharma on Monday announced the launch of Hysingla ER (hydrocodone bitartrate) extended-release tablets CII. According to the company, the once-daily drug is the first and only hydocodone product to be recognized by the Food and Drug Administration as having properties that deter misuse and abuse via chewing, snorting and injection.

January 14, 2015

The University of Florida's Pharm.D. program recently released an infographic around the risks associated with acetaminophen use. 

December 30, 2014

Vertex Pharmaceuticals has announced that the Food and Drug Administration approved a supplemental new drug application for the use of Kalydeco (ivacaftor) in people with cystic fibrosis ages 6 years and older who have the R117H mutation in the cystic fibrosis transmembrane conductance regulator gene.

December 22, 2014

Mylan has announced the U.S. launch of its Estradiol Transdermal System USP, 0.025 mg/day, 0.0375 mg/day, 0.05 mg/day, 0.075 mg/day and 0.1 mg/day (twice weekly), which is the generic version of Novartis' Vivelle-DOT.

December 11, 2014

Teva Pharmaceuticals on Thursday announced the availability of levalbuterol inhalation solution, USP (concentrate), a generic equivalent to Xopenex inhalation solution concentrate. 

December 2, 2014

Teva Pharmaceuticals on Monday announced the introduction and availability of Buprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate Sublingual Tablets, CIII.

November 20, 2014

Purdue Pharma on Thursday announced that the Food and Drug Administration approved Hysingla ER (hydrocodone bitartrate) extended‐release tablets CII, a once‐daily, single‐entity medication formulated using Purdue’s proprietary extended‐release solid oral platform, Resistec.

October 28, 2014

The Acetaminophen Awareness Coalition on Tuesday kicked off its annual “Double Check; Don’t Double Up” campaign.

October 22, 2014

Pfizer last week announced that the Food and Drug Administration approved a revised label for Embeda (morphine sulfate and naltrexone hydrochloride) extended-release capsules, for oral use, CII, to include abuse-deterrence studies. 

 

October 17, 2014

Purdue Pharma has launched an awareness campaign to address specific knowledge gaps among pharmacists related to its Schedule III extended-release transdermal opioid, Butrans.

October 9, 2014

The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products. 

October 9, 2014

Purdue Pharma on Thursday announced the launch of a new dosage strength of 7.5 mcg/hour for its Butrans (buprenorphine) transdermal system CIII, bringing the total number of strengths offered by the company to five.