Content about U.S. Food and Drug Administration

March 25, 2014

The Drug Store News Group, the leading provider of news, information and clinical education for the retail pharmacy industry, has launched the new microsite, Drugstorenews.com/pain-management, to help bring attention to another tragic side of the prescription drug abuse story — the millions of Americans who live in chronic pain that may be unable to access the medications they need thanks to proposed changes in regulatory policy.

NEW YORK — The Drug Store News Group, the leading provider of news, information and clinical education for the retail pharmacy industry, has launched the new microsite, Drugstorenews.com/pain-management, to help bring attention to another tragic side of the prescription drug abuse story — the millions of Americans who live in chronic pain that may be unable to access the medications they need thanks to proposed changes in regulatory policy.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

MAPLE GROVE, Minn. — Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

Qudexy XR will be available to patients in second quarter 2014.

February 28, 2014

The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

WASHINGTON — The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

DUBLIN — Perrigo Co. announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets — in 1-mg and 2-mg strengths. The company has started shipment of the drug. Perrigo previously launched the 0.5-mg strength in 2013.

January 17, 2014

Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%

MISSISSAUGA, Ontario — Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%.

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

WHITEHOUSE STATION, N.J. — Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar. Vorapaxar is the company’s investigational antiplatelet medicine for the reduction of atherothrombotic events, when added to standard of care, in patients with a history of heart attack and no history of stroke or transient ischemic attack.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

August 13, 2013

The Food and Drug Administration approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

WASHINGTON — The U.S. Food and Drug Administration on Monday approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

Tivicay is an integrase strand transfer inhibitor that interferes with one of the enzymes necessary for HIV to multiply. It is a pill taken daily in combination with other antiretroviral drugs.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

WASHINGTON — The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

DEERFIELD, Ill. — Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the U.S. Food and Drug Administration. Onfi is a prescription medication originally approved by the FDA in 2011, and is used along with other medicines to treat seizures associated with Lennox-Gastaut syndrome (LGS) in adults and children 2 years of age or older. Onfi is an oral anti-epileptic drug (AED) of the benzodiazepine class, and is a 1,5 benzodiazepine.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

ALLEGAN, Mich. — Perrigo Co. today announced that it has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil. Perrigo expects to begin shipments of both products next month.

August 8, 2013

Eisai announced that the Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma.

WOODCLIFF LAKE, N.J. — Eisai Inc., announced today that the U.S. Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma. E7777 is designed to have an improved purity profile and manufacturing process. It is currently in a pivotal trial intended to support its submission for approval.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

NEW YORK — Keryx Biopharmaceuticals, Inc., today announced the submission of a new drug application to the U.S. Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

May 17, 2013

More than two-thirds of patients with hepatitis C achieved sustained virologic response or cure after completing newer “triple therapy” treatment, according to a Walgreens Specialty Pharmacy study released Friday.

DEERFIELD, Ill. — More than two-thirds of patients with hepatitis C achieved sustained virologic response or cure after completing newer “triple therapy” treatment, according to a Walgreens Specialty Pharmacy study released Friday. 

April 16, 2013

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

HAWTHORNE, N.Y. — Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

Topicort topical spray, 0.25% is a corticosteroid indicated for the treatment of plaque psoriasis in patients 18 years of age or older.

According to Taro, the corticosteroid spray market is approximately $100 million in annual sales in the United States.

April 1, 2013

GlaxoSmithKline Consumer Healthcare today commended the proposals by the U.S. Food and Drug Administration after the administration announced recommendations to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy products.

PARSIPPANY, N.J. — GlaxoSmithKline Consumer Healthcare today commended the proposals by the U.S. Food and Drug Administration after the administration announced recommendations to remove certain warning statements and modifications of the instructions for use of nicotine replacement therapy products.

According to the statement released by GSK Consumer Healthcare:

January 2, 2013

The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

WASHINGTON — The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

Tuberculosis is an air-spread infection that usually attacks the lungs, but also affect the brain, the spine and the kidneys. The drug blocks an energy-producing enzyme the tuberculosis bacteria needs to survive and is the first drug in 40 years to attempt to cure the disease using this type of treatment.

January 2, 2013

Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets and rizatriptan benzoate tablets, generic versions of Merck's Maxalt MLT Tablets and Maxalt Tablets.

PITTSBURGH — Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets, 5 mg and 10 mg, and rizatriptan benzoate tablets, 5 mg and 10 mg. These products are the generic versions of Merck's Maxalt MLT® Tablets and Maxalt® Tablets, respectively, and are indicated for the acute treatment of migraine with or without aura in adults.

January 2, 2013

The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

SPRING SPRING, Md. — The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection. Diarrhea is experienced by many HIV/AIDS patients and is a common reason why patients discontinue or switch their antiretroviral therapies.

December 28, 2012

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

 PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

The product is a generic version of Pfizer's Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.

December 28, 2012

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

PITTSBURGH — Mylan on Friday announced that its partner Famy Care has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol tablets USP in the 0.15mg/0.03mg strength.

The product is a generic version of Teva Branded Pharmaceutical Products' Nordette 28 Tablets, a form of oral contraception. The new product will be distributed in the United States by Mylan Pharmaceuticals, and the company is shipping the product immediately.

December 28, 2012

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

PARSIPPANY, N.J. — Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the U.S. Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

Bortezomib is a proteasome inhibitor for intravenous or subcutaneous administration, approved for treatment of patients with multiple myeloma and patients with mantle cell lymphoma who have received at least one prior therapy.

November 28, 2012

Regional life sciences association Biocom has introduced a new eco-friendly alternative to sanitary napkins and tampons. Enter FemmyCycle, a product from member FemCap.

SAN DIEGO — Regional life sciences association Biocom has introduced a new eco-friendly alternative to sanitary napkins and tampons. Enter FemmyCycle, a product from member FemCap.

The FemmyCycle was granted clearance by the U.S. Food and Drug Administration on Nov. 16. FemmyCycle creator Alfred Shihata is familiar with developing feminine products. His FDA-approved FemCap is one of the few hormone-free, woman-controlled contraceptive methods available.

November 15, 2012

As the U.S. Senate and House of Representatives examined the meningitis outbreak this week, the National Association of Chain Drug Stores distinguished between the types of pharmacy compounding and the settings in which they take place, and emphasized the critical, life-saving benefits of pharmacy compounding.

ALEXANDRIA, Va. — As the U.S. Senate and House of Representatives examined the meningitis outbreak this week, the National Association of Chain Drug Stores distinguished between the types of pharmacy compounding and the settings in which they take place, and emphasized the critical, life-saving benefits of pharmacy compounding.

NACDS stated that it has sent a letter to members of the U.S. Senate Committee on Health, Education, Labor and Pensions and the U.S. House Committee on Energy and Commerce — both of which held hearings on the outbreak on Nov. 14.

October 16, 2012

Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

ALLEGAN, Mich. — Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

Zegerid OTC (omeprazole and sodium bicarbonate capsules 20 mg/1,100 mg), a proton-pump inhibitor indicated to relieve frequent heartburn, had sales of approximately $42 million through food, drug and mass merchandisers for the lastest 12 months.