Content about Food and Drug Administration

November 19, 2012

The year 2012 is coming to an end, and it's been a big year for generic drugs. It's the year that the most lucrative drug of all time became commoditized. It's the year that Watson bought Actavis for $5.6 billion. And it's the year the FDA released draft guidance for biosimilars regulations. All of these events speak to some of the most important trends in the world of generics — trends that are often interrelated.

April 18, 2014

Merck on Thursday announced that the Food and Drug Administration has approved Ragwitek (short ragweed pollen allergen extract) tablet for sublingual use (12 Amb a 1-U).

April 15, 2014

The Food and Drug Administration on Friday announced a meeting of the Nonprescription Drugs Advisory Committee on May 2 to discuss the potential switch of Merck's Singulair Allergy tablets.

April 15, 2014

Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use.

April 15, 2014

The Food and Drug Administration on Tuesday announced that it approved Tanzeum (albiglutide) subcutaneous injection, which is used to improve glycemic control in adults with Type 2 diabetes.

April 14, 2014

The Biotechnology Industry Organization and the Delaware BioScience Association last week commended the Delaware State Senate for passing legislation designed to create a pathway for the substitution of interchangeable biologic medicines.

April 11, 2014

Mylan on Friday confirmed that a federal district court has granted its request to enforce a settlement agreement between Endo Pharmaceuticals and Mylan settling patent litigation in connection with Mylan's filing of an abbreviated new drug application with the Food and Drug Administration for frovatriptan succinate tablets, 2.5 mg.

April 10, 2014

Lupin announced that it received final approval from the Food and Drug Administration for pioglitazone tablets USP in 15-mg, 30-mg and 45-mg strengths.

April 8, 2014

Healthcare Distribution Management Association president and CEO John Gray on Monday testified before the House Energy and Commerce Subcommittee on Health at a hearing on “Improving Predictability and Transparency in DEA and FDA Regulation.”

April 8, 2014

The Natural Products Association on Tuesday named Daniel Fabricant the association's new CEO.

April 8, 2014

Sunovion Pharmaceuticals on Monday announced that Aptiom (eslicarbazepine acetate), a once-daily antiepileptic drug, is now available across the United States.

April 8, 2014

Teva Pharmaceutical Industries announced that it has received approval from the Food and Drug Administration for its generic form of Lovaza (omega-3-acid ethyl esters capsules, USP) in the United States.

April 7, 2014

Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate), which is used to treat deep venous thrombosis and pulmonary embolism.

April 7, 2014

The National Association of Chain Drug Stores submitted a written statement in lead-up to Monday’s hearing of the U.S. House Committee on Energy and Commerce Subcommittee on Health urging transparency in how federal agencies conduct enforcement activities to help curb prescription drug diversion and abuse.

April 4, 2014

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April 4, 2014

The National Association of Boards of Pharmacy recommended that pharmacies no longer dispense combination drugs containing more than 325 mg of acetaminophen per dosage unit in light of recent regulatory action.

April 3, 2014

Axium Healthcare Pharmacy announced that it will begin to dispense Otezla, the new oral therapy for the treatment of adults with active psoriatic arthritis.

April 3, 2014

MannKind Corp. on Tuesday announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the Food and Drug Administration voted 13-to-1 to recommend that Afrezza (insulin human [rDNA origin]) inhalation powder be granted marketing approval by the FDA to improve glycemic control in adults with Type 1 diabetes and voted 14-to-0 to recommend that Afrezza be granted marketing approval by the FDA to improve glycemic control in adults with Type 2 diabetes.

April 3, 2014

The Food and Drug Administration on Thursday approved a prescription treatment that can be used by family members or caregivers to treat a person known or suspected to have had an opioid overdose.

April 2, 2014

Greer Labs, a developer and provider of allergy immunotherapy products and services, announced that the Food and Drug Administration has approved Oralair (Sweet Vernal, Orchard, Perennial Rye, Timothy and Kentucky Blue Grass mixed pollens allergen extract) sublingual allergy immunotherapy tablet.

March 31, 2014

Just days after the Food and Drug Administration approved Otezla, a new oral therapy to treat active psoriatic arthritis in adult patients, Avella Specialty Pharmacy on Friday announced that it is prepared to begin distributing the drug.

March 31, 2014

The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years.

March 31, 2014

The Food and Drug Administration on Friday approved over-the-counter Nexium 24HR (esomeprazole 20mg), Pfizer announced.

March 28, 2014

DSN recently launched a new microsite, DrugStoreNews.com/Pain-Management, to bring attention to a tragic side of the prescription drug abuse story — one that's not often told. The millions of Americans who live in chronic pain who already find it difficult to access the medications they need may soon find it even more difficult — because proposed changes in regulatory policy are expected to place additional hurdles on their treatment pathway.

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