Content about Food and Drug Administration

April 4, 2013
Valeant earnings per share could take hit in 2013 from herpes ointment generic

The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

MONTREAL — The Food and Drug Administration approval this week of a generic genital herpes ointment made by Mylan could make a slight dent in the stock price of the company that makes the branded version.

Canada-based Valeant Pharmaceuticals International said that while it expected Mylan to receive approval for a generic version of Zovirax (acyclovir) ointment, it did not include the approval in its original budget expectations and thus expected its earnings per share in fiscal year 2013 to be reduced by 30 to 40 cents.

April 3, 2013
FDA approves Mylan genital herpes ointment

The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said.

PITTSBURGH — The Food and Drug Administration has approved a new drug for genital herpes made by Mylan, the drug maker said Wednesday.

Mylan announced the approval of acyclovir ointment in the 5% strength. The drug is a generic version of Valeant International's Zovirax, used to manage initial genital herpes and in limited, non-life-threatening mucocutaneous herpes simplex virus infections in patients with compromised immune systems.

April 3, 2013
FDA approves new allergy drug for children

The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said.

MONMOUTH JUNCTION, N.J. — The Food and Drug Administration has approved a new drug for allergies in children made by Tris Pharma, the drug maker said Wednesday.

Tris announced the approval of Karbinal ER (carbinoxamine maleate) extended-release oral suspension in the 4 mg-per-five milliliter strength. The company said the drug was the first sustained-release histamine receptor blocking agent for seasonal and perennial allergic rhinitis in children 2 and older.

April 2, 2013
Federal court rules in favor of Actavis in generic asthma drug case

A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

PARSIPPANY, N.J. — A court has ruled in favor of generic drug maker Actavis concerning its generic version of a drug to treat asthma in children, the company said.

April 1, 2013
Actavis seeks approval for additional strength of generic testosterone gel

Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

PARSIPPANY, N.J. — Just a week after the Supreme Court heard the Federal Trade Commission's lawsuit over its deal with AbbVie to sell a generic version of a testosterone-replacement therapy, Actavis is challenging the patent on another strength of the drug.

Actavis said Monday that it had filed with the Food and Drug Administration for approval of testosterone gel in the 1.62% strength. The drug is a generic version of AbbVie's AndroGel 1.62%. The case that went before the Supreme Court on March 25 concerns the 1% strength of AndroGel.

April 1, 2013
FDA approves new Teva contraceptive

The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

JERUSALEM — The Food and Drug Administration has approved a new contraceptive therapy made by Teva Pharmaceutical Industries, Teva said Monday.

The drug maker announced the approval of Quartette (levonorgestrel, ethinyl estradiol and ethinyl estradiol) tablets. Teva said the drug represented the "next generation" of extended-regimen oral contraceptives and was designed to minimize breakthrough bleeding between scheduled periods.

April 1, 2013
GSK Consumer Healthcare commends FDA nicotine replacement therapy proposals

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:

March 29, 2013
FDA approves J&J diabetes drug

The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Johnson & Johnson for treating Type 2 diabetes, the agency said.

The FDA announced the approval of J&J subsidiary Janssen Pharmaceuticals' Invokana (canagliflozin) tablets, designed for use with diet and exercise to improve blood-sugar control in adults with the disease.

March 29, 2013
FDA proposes regulations for meetings between agency, biosimilar makers

The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

SILVER SPRING, Md. — The Food and Drug Administration is seeking comment from drug makers and others concerning formal meetings between the agency and companies looking to market follow-on biologics.

March 27, 2013
FDA approves Aciphex Sprinkle capsules

The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

WOODCLIFF LAKE, N.J. — The Food and Drug Administration has approved a treatment made by Eisai for gastroesophageal reflux disease in children ages 1 year to 11 years, the drug maker said.

Eisai announced the approval of Aciphex Sprinkle (rabeprazole sodium) delayed-release capsules.

March 27, 2013
FDA approves injectable antihistamine using BD Simplist

The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

FRANKLIN LAKES, N.J. — The Food and Drug Administration has approved a drug administered through a new line of injection devices made by BD, the company said Wednesday.

BD announced the approval of diphenhydramine hydrochloride injection, an antihistamine, packaged in its recently launched Simplist pre-filled injectables, which are made by subsidiary BD Rx and designed to improve patient care and safety by decreasing the number of steps in the traditional vial and syringe injection sequence and thus reduce the potential risk of medication errors.

March 27, 2013
FDA approves new MS drug

The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has approved a new treatment for multiple sclerosis made by Biogen Idec, the agency said Wednesday.

The FDA announced the approval of Tecfidera (dimethyl fumarate) capsules for adults with relapsing forms of MS.

March 26, 2013
FDA approves Actavis drug for opioid dependence

The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

PARSIPPANY, N.J. — The Food and Drug Administration has approved a drug for opioid dependence made by Actavis, the company said.

Actavis announced the approval of buprenorphine hydrochloride and naloxone hydrochloride dehydrate sub-lingual tablets in the 2 mg/0.5 mg and 8 mg/2 mg strengths.

The drug is a generic version of Reckitt Benckiser's Suboxone, which had sales of about $625 million in 2012, according to IMS Health.

 

March 26, 2013
FDA delays approval of GSK vaccine

The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

LONDON — The Food and Drug Administration has declined to approve a bird flu vaccine made by GlaxoSmithKline due to an administrative issue, the drug maker said.

GSK said it received a complete response letter from the FDA for its vaccine for pandemic influenza A virus monovalent adjuvanted candidate vaccine, also known as Q-Pan H5N1. The FDA issues a complete response letter when it needs additional time to review a drug application for approval.

March 25, 2013
FDA approves Novartis antibacterial treatment for cystic fibrosis

The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a treatment for managing a type of bacterial infection in patients with cystic fibrosis.

Swiss drug maker Novartis announced the approval of Tobi Podhaler (tobramycin inhalation powder) for managing cystic fibrosis patients with Pseudomonas aeruginosa, or Pa bacteria, in the lungs.

March 25, 2013
Lilly, BI apply for diabetes drug approval

Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said.

RIDGEFIELD, Conn. — Boehringer Ingelheim and Eli Lilly are seeking regulatory approval for an experimental drug to treat Type 2 diabetes, the companies said Monday.

BI and Lilly announced the submission of a regulatory application to the Food and Drug Administration for empagliflozin. The drug belongs to a new drug class known as SGLT2 inhibitors, which work by removing excess glucose through the urine by blocking its reabsorption in the kidneys. The companies are testing the drug in a late-stage clinical trial for which they plan to enroll 14,500 patients.

March 25, 2013
Supreme Court hears patent-settlement case

The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

NEW YORK — The Supreme Court heard arguments Monday in a case that could determine the future of generic drugs in America.

The case, Federal Trade Commission v. Actavis, marks the latest attempt by federal authorities to put an end to what they say are deals between branded and generic drug companies that delay release of generic drugs to consumers.

March 22, 2013
FDA commissioner calls for power to regulate compounding pharmacies

The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

SILVER SPRING, Md. — The commissioner of the Food and Drug Administration is renewing calls for legislation to give the agency more authority to regulate pharmacy compounding.

March 21, 2013
FDA advises against use of three adulterated drug products

The Food and Drug Administration advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients.

BETHESDA, Md. — The Food and Drug Administration on Thursday advised consumers not to purchase or use three separate sexual enhancement products that are being promoted as dietary supplements because they contain undeclared and unapproved prescription-only ingredients. 

March 21, 2013
Ga. compounding pharmacy recalls all lots of sterile products

A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said.

SILVER SPRING, Md. — A compounding pharmacy in Georgia is recalling all of its sterile products following a Food and Drug Administration investigation that found possible lack of proper sanitation procedures, the FDA said Thursday.

March 21, 2013
Va. governor signs first state bill to limit biosimilars

Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

WASHINGTON — Gov. Bob McDonnell of Virginia has signed into law the first bill that could limit the reach of follow-on biologics, though the bill includes a two-year sunset clause, meaning it will expire in 2015.

McDonnell signed House bill 1422 and the identical Senate bill 1285, which would prevent a pharmacist from dispensing a biosimilar to substitute for the original, branded biologic if the prescriber indicated that substitution was not allowed or if the patient insisted on receiving the branded product.

March 20, 2013
Doctors, public health experts want more FDA regulation of energy drinks

A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

NEW YORK — A group of doctors and public health professors are hoping the Food and Drug Administration will place stronger regulations on energy drinks to protect children and adolescents from what they call the harmful effects of high caffeine consumption.

March 20, 2013
Sandoz launches generic contraceptives

The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

PRINCETON, N.J. — The Food and Drug Administration has approved and launched two generic contraceptives made by Sandoz, the drug maker said.

Sandoz, the generics division of Swiss drug maker Novartis, announced the approval of Estarylla (norgestimate and ethinyl estradiol tablets) and Tri-Estarylla (norgestimate and ethinyl estradiol tablets), generic versions of Johnson & Johnson's Ortho Cyclen and Ortho Tri-Cyclen, respectively. Sandoz said the launches brought the total number of oral contraceptives it has launched since the beginning of 2011 to six.

March 19, 2013
FDA picks acting director for Office of Generic Drugs

The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said.

SILVER SPRING, Md. — The Food and Drug Administration has picked Kathleen Uhl to serve as acting director of the Office of Generic Drugs, the agency said Tuesday.

In a memo sent out to staff of the Center for Drug Evaluation and Research, the section of the agency that oversees the OGD, CDER director Janet Woodcock wrote that Uhl most recently served as senior adviser to director Greg Geba, who announced his resignation Thursday.

March 19, 2013
GAO pushes FDA for final NDI guidance to improve enforcement efforts

The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients.

WASHINGTON — The U.S. Government Accountability Office on Monday advised the Food and Drug Administration to establish a time frame on New Dietary Ingredient guidance, as well as guidance clarifying whether a liquid product may be labeled and marketed as a dietary supplement or as a conventional food with added ingredients. Those two guidelines will help the agency use adverse event reports in overseeing dietary supplement products, the GAO stated.