Content about Food and Drug Administration

May 16, 2011

The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

SILVER SPRING, Md.— The Food and Drug Administration has approved a new treatment for chronic hepatitis C, the agency said Friday.

The FDA announced the approval of Merck’s Victrelis (boceprevir) for patients with the disease. The drug is designed for patients who still have some liver function and have not previously received treatment for chronic hepatitis C infection or have failed previous treatments. The drug is approved for use in combination with the generic drug ribavirin and pegylated interferons, biotech drugs used for treating the disease.

May 13, 2011

More than 800 drugs are in development for diseases that affect women, according to a pharmaceutical industry lobbying group.

WASHINGTON — More than 800 drugs are in development for diseases that affect women, according to a pharmaceutical industry lobbying group.

May 11, 2011

The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.

WASHINGTON — The American Pharmacists Association has published its white paper on risk evaluation and mitigation strategies, the group said.

May 11, 2011

A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.

TUCKER, Ga. — A recent Food and Drug Administration inspection prompted the recall of dietary supplements distributed by Multi-Mex Distributor, the company announced Monday. According to an FDA post, the supplements in question bore a close resemblance to antibiotics available in Mexico and may have been confusing to Hispanic consumers.

May 11, 2011

Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.

SOUTH SAN FRANCISCO, Calif. — Genentech is seeking approval for a new drug to treat skin cancer, the company said Wednesday.

May 10, 2011

The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

WAYNE, N.J. — The Food and Drug Administration will expedite its review of an investigational drug made by Bayer HealthCare Pharmaceuticals for treating tumors of the gastrointestinal tract, the company said Tuesday.

May 10, 2011

Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

SWIFTWATER, Pa. — Sanofi’s vaccines division has won Food and Drug Administration approval for a vaccine designed for injection into the skin, the company said Tuesday.

Sanofi Pasteur announced the FDA approval of Fluzone Intradermal (influenza virus vaccine), which injects the vaccine into the skin via a short, fine needle, also known as a microinjection.

May 10, 2011

The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

HAYWARD, Calif. — The branded-drug division of Impax Labs plans to conduct early-stage clinical studies of an investigational drug for restless leg syndrome, the company said Tuesday.

Impax Pharmaceuticals, as the division is known, said it filed an investigational new drug application with the Food and Drug Administration for IPX159 and started a phase-1 study.

May 10, 2011

The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

NEW YORK — The Food and Drug Administration expects to approve an increasing number of drugs, according to published reports.

Reuters quoted FDA Center for Drug Evaluation and Research director Janet Woodcock as saying the number of drugs approved gradually could increase, already having reached a “nadir.” The report noted that 12 drugs had won approval this year so far, and Woodcock speculated that the agency would approve more than the 21 it approved last year.

May 9, 2011

The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration is moving forward in the creation of a regulatory approval pathway for follow-on biologics and is requesting input from stakeholders and the public, the agency said Monday.

The FDA plans to use the input it gets to create a user fee program for regulatory approval applications.

In addition to accepting written comments, the agency will consult with scientific and academic experts, healthcare professionals, patient and consumer advocacy groups and companies.

May 9, 2011

The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

MADISON, Wis. — The Food and Drug Administration has granted orphan drug designation to a treatment made by Mithridion for a rare neurological disorder, Mithridion said Monday.

May 6, 2011

The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a drug made by Novartis as the first treatment for advanced pancreatic neuroendocrine tumors, Novartis said Thursday.

Novartis announced the approval of Afinitor (everolimus), saying it marked the first approval of a drug for advanced pancreatic NET in nearly 30 years. The drug already is approved for treating cancers of the kidneys and brain.

May 5, 2011

The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

SILVER SPRING, Md. — The Food and Drug Administration has unveiled two regulations, part of the newly enacted Food Safety Modernization Act, that will take effect in July.

May 5, 2011

The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.

SILVER SPRING, Md. — The Food and Drug Administration on Wednesday released the Dosage Delivery Devices for Orally Ingested OTC Liquid Drug Products guidance, which outlines how easy-to-use dosage delivery devices and devices that minimize the risk of unintentional overdose can be provided for such over-the-counter medicines as liquid pain relievers, cold medicine, cough syrups and digestion aids.

May 5, 2011

A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

WASHINGTON — A major depressive disorder treatment made by Pfizer significantly reduced the number and severity of moderate-to-severe hot flashes in postmenopausal women, compared with placebo, according to a new study.

May 4, 2011

The Food and Drug Administration is cracking down on companies that it accuses of selling fake products for sexually transmitted diseases, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration is cracking down on companies that it accuses of selling fake products for sexually transmitted diseases, the agency said.

The FDA said at least 15 products — some sold as dietary supplements — that claim to treat, prevent or cure such STDs as herpes, Chlamydia, genital warts and HIV/AIDS, were being sold online and at some retail stores. Brands include MedaVir, which claims to treat herpes; Gene-Eden, which claims to treat a range of STDs, as well as flu and mononucleosis; and several others.

May 4, 2011

The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

PRINCETON, N.J. — The Food and Drug Administration has approved a generic oral contraceptive made by Sandoz, the generics arm of Swiss drug maker Novartis said Wednesday.

Sandoz announced the approval of Loryna (drospirenone 3 mg and ethinyl estradiol 0.02 mg) tablets, a generic version of Bayer HealthCare Pharmaceuticals’ Yaz.

May 3, 2011

Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

PITTSBURGH — Sales at generic drug maker Mylan increased by 12% during first quarter 2011, compared with first quarter 2010, the company said Tuesday.

Sales for the three months ended March 31 were $1.45 billion, compared with $1.29 billion during the same period a year ago. Profits, meanwhile, were $104.2 million, compared with $61.1 million in first quarter 2010.

May 3, 2011

The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

ALLEGAN, Mich. — The Food and Drug Administration has approved a generic version of Rogaine made by Perrigo, the drug maker said.

Perrigo announced the FDA approval of over-the-counter minoxidil foam, a generic version of men’s Rogaine foam.

Stiefel Research Australia, part of GlaxoSmithKline, sued Perrigo for patent infringement when the latter submitted its regulatory approval application. Under a settlement between the companies reached in February, Perrigo can launch its generic version of men’s Rogaine foam in March 2012.

May 2, 2011

The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

ABBOTT PARK, Ill. — The Food and Drug Administration has approved a treatment made by Abbott for low testosterone in men, the drug maker said Friday.

Abbott announced the approval of AndroGel (testosterone gel) in the 1.62% strength, a clear, odorless topical gel for men with hypogonadism. The company already markets AndroGel in the 1% strength.

The new gel contains 40.5 mg of testosterone in two pump presses, while AndroGel 1% contains 50 mg in four pump presses, but the company said the two were not interchangeable.

May 2, 2011

The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for Type 2 diabetes, the agency said Monday.

The FDA announced the approval of Tradjenta (linagliptin), made by Indianapolis-based Eli Lilly and German drug maker Boehringer Ingelheim.

“This approval provides another treatment option for the millions of Americans with Type 2 diabetes,” FDA Division of Metabolism and Endocrinology Products director Mary Parks said. “It is effective when used alone or when added to existing treatment regimens.”

April 29, 2011

The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

HORSHAM, Pa. — The Food and Drug Administration has approved a new treatment for prostate cancer made by Johnson & Johnson.

Centocor Ortho Biotech, J&J’s biotech subsidiary, announced Thursday the approval of Zytiga (abiraterone acetate), a daily pill for use in combination with the corticosteroid prednisone for treating castration-resistant prostate cancer that has spread to other parts of the body in men who have received prior chemotherapy with Sanofi-Aventis’ Taxotere (docetaxel).

April 27, 2011

A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

LIVINGSTON and PARSIPPANY, N.J. — A drug designed to reduce the risk of premature birth among pregnant women has been submitted to the Food and Drug Administration for approval.

April 27, 2011

The Food and Drug Administration is working on creating new and simplified drug information sheets for consumers to replace the multipage and sometimes labyrinthine packets supplied with drugs at retail pharmacies, according to published reports.

NEW YORK — The Food and Drug Administration is working on creating new and simplified drug information sheets for consumers to replace the multipage and sometimes labyrinthine packets supplied with drugs at retail pharmacies, according to published reports.

The Wall Street Journal reported that the agency was testing the information sheets while the U.S. Pharmacopeia Convention was developing a new standard for drug labels.

April 27, 2011

An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

PARIS — An investigational drug helped patients survive longer when combined with chemotherapy as a second-line treatment for colorectal cancer that had spread to other parts of the body, according to results of a late-stage clinical trial announced by French drug maker Sanofi-Aventis and U.S.-based Regeneron Pharmaceuticals.

The phase-3 trial combined the drug Zaltrap (aflibercept) with a combination of the chemotherapy drugs folinic acid (leucovorin), 5-fluorouracil and irinotecan, also known as the FOLFIRI regimen.