Content about U.S. Food and Drug Administration

May 17, 2013
Walgreens pharmacist interventions help improve compliance to newer 'triple therapy' hepatitis C treatment

More than two-thirds of patients with hepatitis C achieved sustained virologic response or cure after completing newer “triple therapy” treatment, according to a Walgreens Specialty Pharmacy study released Friday.

April 16, 2013
Taro receives FDA approval for Topicort topical spray

Taro Pharmaceutical Industries reported last week that it has received approval from the Food and Drug Administration for its new drug application Topicort (desoximetasone) topical spray, 0.25%.

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.

January 2, 2013
FDA approves J&J drug-resistant tuberculosis treatment

The U.S. Food and Drug Administration has approved a new drug from Johnson & Johnson for patients with tuberculosis who do not respond to other treatments, the company announced.

January 2, 2013
FDA approves Mylan's generic Maxalt MLT tablet

Mylan announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its abbreviated new drug applications for rizatriptan benzoate orally disintegrating tablets and rizatriptan benzoate tablets, generic versions of Merck's Maxalt MLT Tablets and Maxalt Tablets.

January 2, 2013
First anti-diarrheal drug for HIV/AIDS patients receives FDA approval

The U.S. Food and Drug Administration on Monday approved Fulyzaq (crofelemer) to relieve symptoms of diarrhea in HIV/AIDS patients taking antiretroviral therapy, a combination of medicines used to treat HIV infection.

December 28, 2012
FDA approves Mylan's generic Dilantin chewable tablets

Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.

December 28, 2012
Mylan launches new generic oral contraceptive

Mylan on Friday announced that its partner Famy Care has received final approval from the Food and Drug Administration for its abbreviated new drug application for levonorgestrel and ethinyl estradiol Tablets USP in the 0.15mg/0.03mg strength.

December 28, 2012
Watson confirms Velcade patent challenge

Watson Pharmaceuticals on Friday confirmed that Actavis, which was acquired by Watson in October, has filed an abbreviated new drug applications with the Food and Drug Administration seeking approval to market bortezomib, a generic version of Millennium Pharmaceuticals' Velcade.

November 28, 2012
Biocom develops alternative to sanitary napkins, tampons

Regional life sciences association Biocom has introduced a new eco-friendly alternative to sanitary napkins and tampons. Enter FemmyCycle, a product from member FemCap.

November 15, 2012
NACDS emphasizes importance of Rx compounding amid congressional hearings on meningitis outbreak

As the U.S. Senate and House of Representatives examined the meningitis outbreak this week, the National Association of Chain Drug Stores distinguished between the types of pharmacy compounding and the settings in which they take place, and emphasized the critical, life-saving benefits of pharmacy compounding.

October 16, 2012
Perrigo wins tentative approval for generic Zegerid OTC

Perrigo has received tentative approval from the U.S. Food and Drug Administration for its abbreviated new drug application to market over-the-counter omeprazole and sodium bicarbonate capsules in the 20-mg/1,100-mg strength, the store-brand equivalent to Merck's Zegerid OTC.

October 15, 2012
Watson gains two generic approvals

Watson Pharmaceuticals announced that its subsidiary, Watson Laboratories, has received Food and Drug Administration approval on its abbreviated new drug application for irbesartan tablets — the generic equivalent to Sanofi's Avapro — in the 75-mg, 150-mg and 300-mg strengths.

August 29, 2012
Abbott's Humira gets support for expanded use

A panel of outside advisers to the Food and Drug Administration has backed wider use for Abbott Labs’ rheumatoid arthritis drug, Humira, for treating a type of inflammatory bowel disease.

April 23, 2012
Rx for a global safety net

In practical everyday terms, does it matter to the community or health system pharmacist that the Food and Drug Administration is forging ties with other agencies worldwide and becoming more international in its outlook and focus? You bet.

April 19, 2012
Personal Care Products Council applauds legislation that advances federal oversight

The Personal Care Products Council and the Safe Cosmetics Alliance has announced support for legislation to strengthen and modernize regulatory oversight of the industry and to create a greater role for the Food and Drug Administration in assessing the safety of personal care products.

March 8, 2012
NACDS expresses pharmacy's commitment to patient safety in House Panel testimony

Written testimony submitted by the National Association of Chain Drug Stores underscored chain pharmacies’ commitment to patient safety as part of the next Prescription Drug User Fee Act reauthorization, and emphasized that community pharmacist-provided services help improve health outcomes without the introduction of unproven technologies.

December 23, 2010
FDA approves Watson oral contraceptive

The Food and Drug Administration has approved the first and only low-dose oral contraceptive to combine 0.8-mg norethindrone and 0.025-mg ethinyl estradiol in a chewable form, with four 75-mg ferrous fumarate (iron) placebo tablets, Watson Pharmaceuticals has announced.

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