Content about Food and Drug Administration

April 2, 2013

DSN caught up with Greg Bradley — president and CEO of Advantage Consumer Healthcare, a full turnkey solution center for over-the-counter medicines reaching the market — for an overview of the new marketing and sales solution company as it has recently brought to market OraSure Technologies' OraQuick Advance, a take-home HIV test kit that the Food and Drug Administration recently approved for the self-care market, and Westport Pharmaceuticals' Zephrex-D, a pseudoephedrine product with a unique point of differentiation.

AUDIO Q&A: DSN caught up with Greg Bradley — president and CEO of Advantage Consumer Healthcare, a full turnkey solution center for over-the-counter medicines reaching the market — for an overview of the new marketing and sales solution company as it has recently brought to market OraSure Technologies' OraQuick Advance, a take-home HIV test kit that the Food and Drug Administration recently approved for the self

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 And it's the year the FDA released draft guidance for biosimilars regulations.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.

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 And it's the year the FDA released draft guidance for biosimilars regulations.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).

WHITEHOUSE STATION, N.J. — 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). Ragwitek is an allergen extract indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis with or without conjunctivitis. Ragwitek is approved for use in adults ages 18 years through 65 years. 

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.

SILVER SPRING, Md. — 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. 

The proposed OTC use is "temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: Nasal congestion, runny nose, itchy, watery eyes, sneezing, itching of the nose.” The applicant proposes to label the product for OTC use in adults 18 years and older. 

April 15, 2014

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

WHITEHOUSE STATION, N.J. — Merck announced that the Food and Drug Administration has approved Grastek (Timothy grass pollen allergen extract) tablet for sublingual use. The drug is an allergen extract used for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis. It is approved for use in persons ages 5 years through 65 years of age.

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.

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

Type 2 diabetes affects approximately 24 million people and accounts for more than 90% of diabetes cases diagnosed in the United States.

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.

WASHINGTON — 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.

The Delaware State Senate passed Senate Substitute 1 for Senate Bill 118. 

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.

PITTSBURGH — 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. This product is the generic version of Frova, which is used to treat acute migraine headaches in adults. 

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.

MUMBAI and BALTIMORE — 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. The product is the generic version of Actos tablets from Takeda Pharmaceuticals.

The drug is used an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes. Actos tablets had annual sales in the United States of approximately $236 million as of December 2013, according to IMS MAT data. 

 

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.”

ARLINGTON, Va. — 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.” HDMA is in support of the Ensuring Patient Access and Effective Drug Enforcement Act of 2014, H.R. 4069, sponsored by Reps. Marino, R-Pa., and Blackburn, R-Tenn. 

April 8, 2014

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

WASHINGTON — The Natural Products Association on Tuesday named Daniel Fabricant the association's new CEO. Fabricant has worked as the director of the Division of Dietary Supplement Programs at the Food and Drug Administration for the past three years, and prior to that was VP global government and scientific affairs for NPA, including serving as active CEO for several months in 2009.  

April 8, 2014

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

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

The drug, which received approval from the Food and Drug Administration on Nov. 8, 2013, is a prescription medicine used with other medicines to treat partial-onset seizures. The drug is available in four table strengths: 200 mg, 400 mg, 600 mg and 800 mg; it can be taken whole or crushed, with food or without.

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.

JERUSALEM — 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.

Lovaza is used as an adjunct to diet to reduce triglycerdide levels in adult patients, according to the FDA. Teva believes it is the first to file and plans to begin shipping immediately.

Lovaza capsules, marketed by GlaxoSmithKline, had annual sales of $1.1 billion in the United States as of December 2013, according to IMS data.

 

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.

RIDGEFIELD, Conn. — Boehringer Ingelheim Pharmaceuticals announced that the Food and Drug Administration has approved Pradaxa (dabigatran etexilate mesylate). The drug is indicated for the treatment of deep venous thrombosis and pulmonary embolism in patients who have received a parenteral anticoagulant for five to 10 days, and to reduce the risk of recurrent DVT and PE in patients who have been previously treated, the company said.

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.

ARLINGTON, Va. — 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.

The hearing is titled “Improving Predictability and Transparency in DEA and FDA Regulation.”  

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.

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

NABP also advises that pharmacists consult with prescribers to discuss alternative products with lower acetaminophen doses.

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.

LAKE MARY, Fla. — Axium Healthcare Pharmacy announced that it will begin to dispense Otezla, the new oral therapy for the treatment of adults with active psoriatic arthritis. Axium is one of a limited number of specialty pharmacies selected by drug manufacturer Celgene to dispense Otezla, which was approved by the Food and Drug Administration on March 21.

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.

VALENCIA, Calif. — 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.

SILVER SPRING, Md. — 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. Evzio (naloxone hydrochloride injection) rapidly delivers a single dose of the drug naloxone via a hand-held auto-injector that can be carried in a pocket or stored in a medicine cabinet. 

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.

LENOIR, N.C. — 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.

PHOENIX — 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. 

At this time, Avella is one of a select number of pharmacies that are contracted by Celgene, the drug manufacturer, to dispense the product at launch.

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.

SILVER SPRING, Md. — The Food and Drug Administration on Friday approved Topamax (topiramate) for prevention of migraine headaches in adolescents ages 12 years to 17 years. This is the first FDA approval of a drug for migraine prevention in this age group. 

The medication is taken on a daily basis to reduce the frequency of migraine headaches.

Topamax was first approved by the FDA in 1996 to prevent seizures. It was approved for migraine prevention in adults in 2004.

March 31, 2014

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

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

“Switching medicines, whenever appropriate, from prescription to non-prescription status improves access, empowers consumers to care for their own health and is an important strategy for Pfizer,” stated Paul Sturman, president, Pfizer Consumer Healthcare. “The FDA approval of Nexium 24HR is a significant milestone in executing against our plan.”

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.

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.