Content about Food and Drug Administration

September 19, 2013

A new research institution set up by the federal government will conduct tobacco-related research around the country using more than $50 million from the Food and Drug Administration and the National Institutes of Health.

SILVER SPRING, Md. — A new research institution set up by the federal government will conduct tobacco-related research around the country using more than $50 million from the Food and Drug Administration and the National Institutes of Health.

September 17, 2013

The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

BALTIMORE — The Food and Drug Administration has approved a generic drug for insomnia made by Lupin, the drug maker said.

The FDA approved zolpidem tartrate extended-release tablets in the 6.25-mg and 12.5-mg strengths, a generic version of Sanofi's Ambien CR.

The branded version of the drug had sales of $366 million during the 12-month period ended in March, according to IMS Health.

 

September 17, 2013

The Food and Drug Administration has approved an injected drug for the bone marrow disorder myelodysplastic syndrome made by Dr. Reddy's Labs, the company said Tuesday.

HYDERABAD, India — The Food and Drug Administration has approved an injected drug for the bone marrow disorder myelodysplastic syndrome made by Dr. Reddy's Labs, the company said Tuesday.

Dr. Reddy's announced the approval of azacitidine injection in the 100-mg-per-vial strength. The drug is a generic version of Celgene's Vidaza, and Dr. Reddy's plans to launch the product in the near future.

Vidaza had sales of about $378.5 million during the 12-month period ended in July, according to IMS Health.

 

September 17, 2013

Stiefel has launched a new drug for treating acne, the company said on Tuesday.

NEW YORK — Stiefel has launched a new drug for treating acne, the company said Tuesday.

Stiefel, which is a subsidiary of British drug maker GlaxoSmithKline, announced the launch of Fabior (tazarotene) foam, which it called the only retinoid in a topical foam formulation for acne vulgaris in patients aged 12 and older.

The drug originally received Food and Drug Administration approval in May 2012.

September 17, 2013

The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

JERUSALEM — The Food and Drug Administration has approved a new formulation of a cancer drug made by Teva Pharmaceutical Industries, Teva said Tuesday.

The Israeli drug maker announced the approval of a liquid formulation of Treanda (bendamustine hydrochloride), which it said would eliminate the need for reconstitution.

The drug is used to treat indolent B-cell non-Hodgkin lymphoma that has progressed during or within six months of treatment with Rituxan (rituximab), which is made by Genentech and Biogen Idec, and in patients with chronic lymphocytic leukemia.

September 16, 2013

Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

PARSIPPANY, N.J. — Actavis has launched a generic drug for post-shingles pain under an agreement with the branded drug's manufacturers, the company said Monday.

Actavis announced the launch of generic lidocaine topical patches in the 5% strength under a settlement agreement with Endo Pharmaceuticals and Teikoku Seiyaku Co. The drug is a generic version of Lidoderm, and Actavis said it was likely the first company to win approval for the generic from the Food and Drug Administration, thus entitling it to 180 days in which to compete exclusively against the branded version.

September 16, 2013

The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a generic chemotherapy pill for treating colorectal and breast cancers, the agency said Monday.

The FDA announced the approval of Teva Pharmaceutical Industries' capecitabine tablets in the 150-mg and 500-mg strengths. The drug is used to treat cancers that have metastasized, meaning they've spread to other parts of the body.

The drug is a generic version of Xeloda, made by Roche division Genentech. According to IMS Health, Xeloda had sales of $706.2 million last year.

 

September 16, 2013

The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

MUMBAI, India — The Food and Drug Administration has approved a drug made by Sun Pharmaceutical Industries for ulcers, Sun said.

Sun announced the approval of lansoprazole delayed-release capsules in the 15-mg and 30-mg strengths.

The drug is a generic version of Takeda's Prevacid delayed-release capsules, which are used for treatment lasting up to four weeks for healing and symptom relief of active duodenal ulcers.

Various versions of the drug have annual sales of about $430 million per year, according to Sun.

 

September 16, 2013

The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

SILVER SPRING, Md. – The Food and Drug Administration is barring the importation of drugs from another one of Ranbaxy Labs' plants in India, the agency said Monday.

September 16, 2013

A drug for treating opioid dependence has been launched, the manufacturer said Monday.

NEW YORK — A drug for treating opioid dependence has been launched, the manufacturer said Monday.

Orexo announced the introduction of Zubsolv (buprenorphine; naloxone) sublingual tablets for the maintenance treatment of opioid dependence. The drug is designed for use as part of a broader treatment regimen that combines drug therapy and counseling.

September 13, 2013

Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

SILVER SPRING, Md. — Companies that make long-acting opioid painkillers will be required to conduct studies to assess their safety, while use of the drugs will be restricted, under new requirements from the Food and Drug Administration.

The agency announced new labeling changes and regulatory requirements for makers of extended-release and long-acting opioids, citing the risk the drugs carry of overdose, abuse and withdrawal. In response, a group also cautioned consumers to be careful when using non-steroidal anti-inflammatory drugs.

September 12, 2013

The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

WASHINGTON — The news that the Food and Drug Administration exceeded its hiring goals for a push that began last year to speed up review of generic drug approval applications is music to the ears of a trade group representing the industry.

September 11, 2013

The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

SILVER SPRINGS, Md. — The Food and Drug Administration has exceeded its goals for hiring new staff as part of a user-fee law for generic drugs, according to an internal memo sent to staff members.

In a memo to staff of the agency's Center for Drug Evaluation and Research, center director Janet Woodcock wrote that for fiscal year 2013, the FDA hired 234 people as part of the Generic Drug User Fee Amendments Human Capital Team. The goal was to hire 231 as part of a three-year push in which it hopes to hire 921, including 461 during fiscal year 2014.

September 11, 2013

A vaccine to slow the progression of HIV and a monoclonal antibody that protects against influenza are among the nearly 300 vaccines under development by drug makers in the United States, according to a new report by a drug industry trade group.

WASHINGTON — A vaccine to slow the progression of HIV and a monoclonal antibody that protects against influenza are among the nearly 300 vaccines under development by drug makers in the United States, according to a new report by a drug industry trade group.

September 10, 2013

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

The Food and Drug Administration is raising the fees that generic drug companies will have to pay when filing for regulatory approval for new products or supplemental applications for existing products, the agency said last month.

September 10, 2013

A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

NEW YORK — A new set of guidelines from the Food and Drug Administration could bring a generic version of a respiratory drug made by GlaxoSmithKline closer to reality.

The FDA guidelines, a set of non-binding recommendations released Monday, outline studies that manufacturers can conduct to determine equivalence between GSK's Advair Diskus (fluticasone propionate; salmeterol xinafoate) and generic versions.

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.

September 10, 2013

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff.

One trend that generic companies and pharmacy retailers alike should keep an eye on is the patent cliff. One of the reasons why generic prescriptions will likely peak at 86% to 87%, Long said, is that after the patent on Crestor expires In 2016, there simply won't be a lot of top-selling branded drugs.

September 10, 2013

Perrigo announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup.

ALLEGAN, Mich. — Perrigo on Tuesday announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug application for cetirizine hydrochloride oral solution USP, 1 mg/mL, bubble gum flavored, the store brand equivalent to Children's Zyrtec Allergy Syrup. Perrigo expects to begin shipments of the product during the upcoming cough/cold/flu season.

September 10, 2013

What a difference a year will make. While sales of antacid tablets were down 1.3% to $2 billion for the 52 weeks ended July 14 across total U.S. multi-outlets, according to IRI, the entire category ought to have made a significant resurgence by this time next year.

What a difference a year will make. While sales of antacid tablets were down 1.3% to $2 billion for the 52 weeks ended July 14 across total U.S. multi-outlets, according to IRI, the entire category ought to have made a significant resurgence by this time next year.

September 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating patients with pancreatic cancer that has spread to other parts of the body, the agency said Friday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a drug made by Celgene for treating patients with pancreatic cancer that has spread to other parts of the body, the agency said Friday.

The FDA announced the approval of Abraxane (paclitaxel protein-bound particles for injectable suspension, albumin-bound) for patients with late-stage forms of the disease. The drug is a chemotherapy treatment already approved for treating breast and lung cancers.

September 6, 2013

The National Community Pharmacists Association on Thursday reiterated its stance on compounding to the House Energy and Commerce Committee of the U.S. House of Representatives.

ALEXANDRIA, Va. — The National Community Pharmacists Association on Thursday reiterated its stance on compounding to the House Energy and Commerce Committee of the U.S. House of Representatives. 

September 6, 2013

More students in middle and high school are using electronic cigarettes, according to data from the Centers for Disease Control and Prevention.

NEW YORK — More students in middle and high school are using electronic cigarettes, according to data from the Centers for Disease Control and Prevention.

In its Morbidity and Mortality Weekly Report Friday, the CDC said that between 2011 and 2012, among students in sixth through 12th grades, e-cigarette use increased from 3.3% to 6.8%.

September 3, 2013

The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

KING OF PRUSSIA, Pa. — The Food and Drug Administration has approved a new vial size for a treatment for a rare immune system disorder.

CSL Behring announced the approval of a 10-g, or 50-mL, vial size for Hizentra (immune globulin subcutaneous [human]). The product is used to prevent infections in patients with primary immunodeficiency, and the new vial size will be available in October.

August 29, 2013

The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved the latest drug in BD's Simplist line, the company said Thursday.

BD announced the approval of ondansetron injection in the 4 mg/2 mL strength, an injectable drug used to prevent nausea and vomiting after surgery. The drug is currently on the FDA's drug shortage list due to recent increases in demand and supply issues faced by other manufactures, BD said.