Content about Food and Drug Administration

April 5, 2013
District Court orders FDA to lift prescription restriction of Plan B One-Step for underage women

The Food and Drug Administration has 30 days to approve over-the-counter availability of the emergency contraceptive Plan B One-Step to women of all ages, according to a decision issued by Judge Edward Korman of the U.S. District Court, Eastern District of New York.

April 4, 2013
Dr. Reddy's launches generic osteoporosis drug

Dr. Reddy's Labs has launched zoledronic acid injection in the 5 mg-per-100-mL strength, the Indian generic drug maker Thursday.

April 4, 2013
FDA grants tentative approval to Aurobindo HIV drug

The Food and Drug Administration has given preliminary approval to a drug made by Aurobindo Pharma for treating HIV infection, the drug maker said.

April 4, 2013
Florida Senate committee passes biosimilar bill

A committee of Florida's state Senate has passed a bill that could limit the use of biosimilars in the state.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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