Content about Food and Drug Administration

August 30, 2010
Sigmapharm files ANDA for generic Hepsera

A generic drug maker has filed an abbreviated new drug application for its version of...

August 29, 2010
BioMarin's Pompe disease treatment gets orphan-drug designation

BioMarin Pharmaceutical on Monday announced its investigational treatment for a lysosomal storage disorder has received...

August 29, 2010
FDA posts new quarterly list from AERS

The Food and Drug Administration has posted a new list of drugs from its Adverse...

August 29, 2010
Industry voices opinion on Ninth Circuit decision of Matrixx Initiatives suit

Industry lobbyists last week weighed in on a Ninth Circuit ruling that allowed for a...

August 29, 2010
MedImmune confirms second CRL from FDA for motavizumab

AstraZeneca's biologics unit has received a second complete response letter from the Food and Drug...

August 26, 2010
FDA approves Amneal generic for treatment of hypertension and liver cirrhosis

The Food and Drug Administration has approved a generic treatment for hypertension and liver cirrhosis...

August 26, 2010
FDA approves single-pill combination of Novartis drugs for high blood pressure

The Food and Drug Administration has approved a single-pill combination of two drugs made by...

August 26, 2010
Topical BioMedics earns patent for product used to treat fibromyalgia pain

Topical BioMedics on Thursday announced that its Topricin pain relief and healing cream has been...

August 25, 2010
FDA gives Sanofi Pasteur the OK to expand use of Menactra vaccine

The Food and Drug Administration has accepted an application from Sanofi Pasteur to expand the...

August 24, 2010
Perrigo gets FDA approval to manufacture milk-based infant formulas

The Food and Drug Administration has given Perrigo the go-ahead to manufacture milk-based infant formulas...

August 23, 2010
Impax Labs pursuing FDA approval for generic cholesterol-lowering drug

Generic drug maker Impax Labs is hoping to win approval for a generic cholesterol-lowering drug....

August 22, 2010
Congress debates FDA role in safety review of personal care products

The Personal Care Products Council announced in July that it is working to create formal...

August 19, 2010
FDA orders nationwide egg recall

Cases of food poisoning in consumers eating eggs from an Iowa-based company have prompted a...

August 19, 2010
FDA recommends expanding the use of Cymbalta

A Food and Drug Administration advisory committee has voted to recommend expanding the use of...

August 18, 2010
FDA grants priority review for Benlysta

The Food and Drug Administration has decided to expedite the review of an investigational drug...

August 17, 2010
FDA grants priority review for Bristol-Myer Squibb's skin cancer treatment

The Food and Drug Administration has agreed to expedite review of an investigational treatment for...

August 17, 2010
Jazz's Xyrem may treat fibromyalgia, FDA advisory committees say

A drug used to treat narcolepsy soon could win approval to treat the chronic pain...

August 17, 2010
NBTY recalls private-label immune system supplements

NBTY on Tuesday announced the recall of its Air Shield, Air Protector, Immune System Support...

August 17, 2010
ProAmatine to be pulled from market, Shire says

Shire has decided to withdraw its blood pressure drug from the market, the drug maker...

August 15, 2010
FDA approves emergency contraceptive Ella

The Food and Drug Administration has approved an emergency contraceptive pill made by a French...

August 15, 2010
FDA may withdraw low blood pressure drug approval

The Food and Drug Administration may rescind its approval of a drug used to treat...

August 15, 2010
Pfizer's Xyntha-administering syringe gets FDA approval

The Food and Drug Administration has approved a prefilled dual-chamber syringe made by Pfizer for...

August 12, 2010
FDA's new video addresses fracture risk when using PPIs

The Food and Drug Administration on Aug. 9 posted a video outlining the revised prescription...

August 12, 2010
Prolatis recalls male-enhancement product

Prolatis earlier this week announced a voluntary nationwide recall of the company’s product sold under...

August 11, 2010
CRN taps FDA's Sharfstein as annual symposium's keynote speaker

The Council for Responsible Nutrition on Thursday announced the Food and Drug Administration's principal deputy...

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