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The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products.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

October 8, 2014

Teva Pharmaceutical Industries on Wednesday announced the initiation of a rolling new drug application submission for hydrocodone bitartrate extended-release tablets.

September 30, 2014

Salix Pharmaceuticals and Progenics Pharmaceuticals announced that the Food and Drug Administration approved Relistor (methylnaltrexone bromide) subcutaneous injection in 12-mg dosage strength to treat constipation in patients taking opioids for chronic, non-cancer pain. 

September 26, 2014

Camber Pharmaceuticals announced the launch of raloxifene hydrochloride, USP tablets in 60-mg dosage strengths.

September 24, 2014

Dr. Reddy's Labs on Wednesday announced the launch of levalbuterol inhalation solution, USP in 0.31-mg, 0.63-mg and 1.25-mg unit-dose vials.

September 16, 2014

The Food and Drug Administration on Tuesday announced approval for Movantik (naloxegol), a treatment for opioid-induced constipation in adults.

September 5, 2014

Purdue Pharma on Thursday shared results from several studies evaluating its investigational pain medication Hysingla ER.

September 3, 2014

Teva Pharmaceutical on Wednesday announced that a positive judgment has been given by the U.K. High Court in support of Teva's case against AstraZeneca relating to the validity of EP 1,085,877 covering the SMART (Single inhaler Maintenance And Reliever Therapy) indication for AstraZeneca's fixed dose formoterol/budesonide combination product, Symbicort.

September 2, 2014

Acura Pharmaceuticals last week announced that it has been awarded a $300,000 grant by the National Institute On Drug Abuse of the National Institutes of Health to fund Phase I development of Acura's new, early stage Limitx abuse deterrent technology.

August 25, 2014

Pharmaceutical company Iroko announced today that a new version its anti-inflammatory drug Zorvolex had been approved by the Food and Drug Administration.

August 5, 2014

Lannett Co. on Monday announced that its abbreviated new drug application for oxycodone hydrochloride capsules, 5 mg, has been approved by the Food and Drug Administration.

July 24, 2014

The Food and Drug Administration approved Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended-release tablets), a long-acting opioid analgesic.

July 22, 2014

The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical for abacavir sulfate and lamivudine tablets, according to agency records.

July 17, 2014

Purdue Pharma announced that the Food and Drug Administration approved a new 7.5-mcg/hour dosage strength of Butrans (buprenorphine) transdermal system CIII.

July 14, 2014

Teva Pharmaceuticals on Monday announced that the Food and Drug Administration has accepted the company's new drug application for albuterol multi-dose dry-powder inhaler, a breath-actuated dry-powder inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease.

July 8, 2014

Purdue Pharma on Tuesday announced that the Food and Drug Administration has granted priority review designation for the company's once-daily, single-entity hydrocodone bitartrate tablet. 

June 30, 2014

Actavis on Monday confirmed that it has filed an abbreviated new drug application with the Food and Drug Administration to market buprenorphine hydrochloride and naloxone hydrochloride dihydrate sublingual tablets.

June 26, 2014

The Acetaminophen Awareness Coalition on Thursday released “Acetaminophen: How It’s Used, Preventing Overdose and What We Can Do to Promote Safe Use,” a report and educational resource to drive safe and appropriate use of one of the United States’ most common drug ingredients.

June 20, 2014

Teva has reached a settlement with Perrigo Pharmaceutical and Catalent Pharma Solutions with respect to four patents for Teva’s ProAir HFA (albuterol sulfate) Inhalation aerosol product.

June 17, 2014

Lannett Co. received approval from the Food and Drug Administration for codeine sulfate tablets USP, a schedule II controlled substance, in 15 mg, 30 mg and 60 mg dosage strengths.

June 17, 2014

As the heroin and opioid epidemic spreads through communities across the United States, Sens. Carl Levin, D-Mich., and Orrin Hatch, R-Utah, will hold a forum on Wednesday to discuss opioid addiction, focusing on the use of buprenorphine to help combat opioid abuse and the obstacles that have prevented even more patients from getting buprenorphine treatment. 


May 29, 2014

Depomed on Wednesday announced that the Food and Drug Administration has accepted for filing a new drug application from Mallinckrodt for MNK-155.