Content about Food and Drug Administration

January 29, 2013

Citizen's Petition asks that behind-the-counter status be mandated for St. John's Wort

Pharmacists Planning Services, Inc. earlier this month filed a Citizen's Petition with the Food and Drug Administration calling to move St. John's Wort, a mood enhancing supplement, behind the counter.

SAN RAFAEL, Calif. — Pharmacists Planning Services, Inc. earlier this month filed a Citizen's Petition with the Food and Drug Administration calling to move St. John's Wort, a mood enhancing supplement, behind the counter.

January 28, 2013

Amneal, South Korea-based Hanmi enter GERD drug deal

U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

BRIDGEWATER, N.J. — U.S. generic drug maker Amneal Pharmaceuticals has entered a deal with South Korean drug maker Hanmi Pharmaceutical to acquire exclusive distribution rights for a Hanmi drug used for treating gastroesophageal reflux disease, Amneal said Monday.

January 28, 2013

FDA accepts application for Genzyme MS drug

The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

CAMBRIDGE, Mass. — The Food and Drug Administration has accepted a regulatory approval application from Genzyme for an experimental treatment for multiple sclerosis, the company said Monday.

Genzyme, a division of French drug maker Sanofi, said the FDA accepted its application seeking approval for Lemtrada (alemtuzumab) for relapsing MS. The company expects the agency to decide whether to approve the drug in the second half of this year.

January 28, 2013

FDA approves new use of Pfizer vaccine

The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

NEW YORK — The Food and Drug Administration has approved a new use for a pneumococcal vaccine made by Pfizer, the drug maker said.

Pfizer announced the approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) for children and adolescents ages 6 years to 17 years for active immunization against the 13 Streptococcus pneumonia serotypes the vaccine covers. For this group, Prevnar 13 is administered as a one-time dose to patients who have never received it.

January 28, 2013

FDA approves three new drugs for Type 2 diabetes

The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved three new drugs for Type 2 diabetes made by Takeda, the agency said Friday.

The FDA announced the approval of Nesina (alogliptin), Kazano (alogliptin and metformin) and Oseni (alogliptin and pioglitazone) tablets.

Alogliptin is a new active ingredient, while metformin and pioglitazone are drugs already on the market.

January 25, 2013

FDA approves Gleevec for most common pediatric cancer

The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

SILVER SPRING, Md. — The Food and Drug Administration has approved a Novartis drug for treating leukemia in children.

The FDA said Friday that it approved Gleevec (imatinib) for treating children newly diagnosed with Philadelphia chromosome-positive acute lymphoblastic leukemia, also known as Ph+ ALL.

January 25, 2013

Merck: FDA approves Oxytrol for Women, creating overactive bladder category in OTC

Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area.

WHITEHOUSE STATION, N.J. — Merck on Friday announced the Food and Drug Administration has approved the switch of Oxytrol for Women (oxybutynin transdermal system, 3.9 mg/day) from prescription-only to nonprescription, creating a new category — overactive bladder in women — in the OTC area. Most notable about this switch is the fact that the FDA approved Oxytrol for Women against the majority opinion of its Nonprescription Drug Advisory Committee, which voted five in favor and six opposed to the switch in November.

January 25, 2013

New indication approved for Genentech drug

The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new use for a cancer drug made by Roche unit Genentech, the agency said.

The FDA announced the approval of Avastin (bevacizumab) combined with fluoropyrimidine-irinotecan or fluoropyrimidine-oxaliplatin chemotherapy for treating colorectal cancer that has spread to other parts of the body, also known as metastatic colorectal cancer, or mCRC.

The drug is also approved for treating lung cancer, kidney cancer and brain cancer.

January 23, 2013

FDA approves Novartis drug for rare blood disorder

The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug for removing excess iron from the blood in patients with a rare genetic disorder, the agency said.

The FDA announced the approval of Novartis' Exjade (deferasirox) for patients ages 10 years and older with chronic iron overload resulting from nontransfution-dependent thalassemia, or NTDT. A companion diagnostic, FerriScan, made by Australia-based Resonance Health, also was approved.

January 22, 2013

FDA addresses Tamiflu shortages

The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

ATLANTA — The Food and Drug Administration on Friday approved the distribution of 2 million additional doses of Tamiflu (oseltamivir phosphate) 75 mg that contain an older version of the package insert.

January 22, 2013

FDA approves Lupin contraceptive

The Food and Drug Administration has approved a generic contraceptive made by Lupin Pharmaceuticals, the drug maker said Tuesday.

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

Lupin announced the approval of levonorgestrel and ethinyl estradiol tablets in the 0.1 mg/0.02 mg strength, a generic version of Watson Labs' Lutera.

Lutera had sales of about $103.6 million during the 12-month period that ended in September 2012, according to IMS Health.

January 21, 2013

GSK submits approval application for albiglutide

Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

LONDON — Drug maker GlaxoSmithKline is seeking Food and Drug Administration approval for a new treatment for Type 2 diabetes, the drug maker said.

GSK announced the submission to the FDA of a regulatory approval application for albiglutide. The drug is not approved in any market yet, and the company plans to also seek approval in the European Union this year.

GSK assumed control of albiglutide with its $3.6 billion acquisition of Human Genome Sciences, announced last July.

January 21, 2013

Reports: State legislation targets biosimilar substitution

While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

NEW YORK — While regulations for biosimilars work their way through the Food and Drug Administration, state governments are already looking at legislation concerning the substitution of biosimilars for their branded counterparts, according to a legal affairs blog focused on the FDA.

In a post Friday on FDA Law Blog, the official blog of the law firm Hyman, Phelps & McNamara, attorney Kurt Karst wrote that several states were laying the groundwork for such legislation, recalling state-level antisubstitution laws targeting generics that were adopted in the 1970s.

January 18, 2013

Reports: Roche dips into Tamiflu reserve

The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

NEW YORK — The Food and Drug Administration is allowing Roche to tap its reserves of the flu drug Tamiflu, according to published reports.

Reuters reported that the Swiss drug maker would start selling its reserve stock of the adult formulation of the drug, whose chemical name is oseltamivir.

The FDA has reported spot shortages of the pediatric formulation of the drug, but has said pharmacists can break open the capsules and dissolve it in liquid to create a substitute. Meanwhile, a shortage of the adult formulation has appeared in Canada.

January 17, 2013

FDA approves Flublok, a trivalent influenza vaccine not made with eggs

The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday approved Protein Sciences' Flublok, the first trivalent influenza vaccine made using an insect virus (baculovirus) expression system and recombinant DNA technology.

January 17, 2013

FDA approves sterile blood-plasma product

The Food and Drug Administraiton has approved a drug for replacing clotting proteins in the blood for conditions in which patients have too little of them.

SILVER SPRING, Md. — The Food and Drug Administraiton has approved a treatment for replacing clotting proteins in the blood for conditions in which patients have too little of them.

The FDA announced the approval of Octapharma's Octaplas, a sterile, frozen solution of pooled human plasma from multiple donors that has been treated with a solvent detergent process.

January 17, 2013

SIDI Work Group releases voluntary supplier qualification guidelines

The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.

WASHINGTON — The dietary supplement industry’s self-regulatory coalition, the SIDI Work Group, on Thursday announced the release of its voluntary Dietary Supplement Component Supplier Qualification Guideline — a document designed to assist the industry in supply chain integrity, which is a requirement for complying with current good manufacturing practices.

January 16, 2013

FDA approves Uceris for ulcerative colitis

The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

SAN DIEGO — The Food and Drug Administration has approved an ulcerative colitis drug made by Santarus, the drug maker said.

Santarus announced the approval of Uceris (budesonide) extended-release tablets for mild to active UC. The company plans to launch the drug in March.

January 16, 2013

FDA sets generic drug user fee rates for 2013

The Food and Drug Administration has set user fee rates for generic drug companies, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has set user fee rates for generic drug companies, the agency said Wednesday.

The FDA announced that it had published a notice in the Federal Register for companies that make finished dosage forms, meaning drugs in their final form, and active pharmaceutical ingredients, meaning the main ingredients of the drugs.

January 15, 2013

Reports: Alabama man can sue branded drug makers over generic drug side effects

The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

NEW YORK — The state supreme court in Alabama ruled that brand-name drug companies could be sued if patients suffer complications from generic versions of their medicines, according to published reports.

According to The New York Times, an Alabama man named Danny Weeks claimed he developed tardive dyskinesia after taking generic versions of Pfizer's acid reflux drug Reglan (metoclopramide). Pfizer acquired rights to the drug when it bought Wyeth in 2009, and generic drug makers Teva and Actavis, now owned by Watson, make generic versions.

January 14, 2013

U.S., Canadian health authorities report spot shortages of Tamiflu

As if the reported spot shortages of flu vaccine aren't bad enough, there have been reports of similar shortages of flu drugs throughout the United States and parts of Canada due to increased demand.

January 11, 2013

FDA panel recommends approval for J&J Type 2 diabetes drug

A panel of Food and Drug Administration experts has recommended approval for an experimental Type 2 diabetes drug made by Johnson & Johnson, the drug maker said.

RARITAN, N.J. -- A panel of Food and Drug Administration experts has recommended approval for an experimental Type 2 diabetes drug made by Johnson & Johnson, the drug maker said.

J&J said the FDA's Endocrinologic and Metabolic Drugs Advisory Committee had recommended approval for canagliflozin, which the company plans to market under the name brand Invokana. The FDA is not required to follow the votes of advisory committees when deciding whether or not to approve a drug, but usually does.

January 10, 2013

FDA approves Bayer IUD

The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

WAYNE, N.J. — The Food and Drug Administration has approved a new intrauterine device for preventing pregnancy made by Bayer HealthCare Pharmaceuticals, the drug maker said.

Bayer announced the approval of Skyla (levonorgestrel-releasing uterine system), which can prevent pregnancy for up to three years. The IUD contains 13.5 mg of levonorgestrel.

Nearly 50% of pregnancies in the United States are unintended, according to the National Center for Health Statistics.

January 10, 2013

FDA approves Wockhardt epilepsy drug

The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a generic epilepsy drug made by Wockhardt, the company said.

Wockhardt, based in India, announced the approval of lamotrigine extended-release tablets in the 25-mg, 50-mg, 100-mg, 200-mg and 300-mg strengths.

The drug is a generic version of GlaxoSmithKline's Lamictal XR. The U.S. market for the drug is about $250 million, according to IMS Health.

January 10, 2013

FDA calls for lower dosage in some insomnia drugs

The Food and Drug Administration is ordering the makers of several sleep drugs to lower the dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

SILVER SPRING, Md. — The Food and Drug Administration is ordering the makers of several sleep drugs to lower the recommended dosage due to the risk that they can impair patients the morning after, the agency said Thursday.

The FDA announced that it was requiring the manufacturers of drugs containing the active ingredient zolpidem to lower the current recommended dosage in light of new data showing that the morning after use, the drug can remain in the blood in sufficient quantities to impair activities that require alertness, such as driving.