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August 30, 2012

The Food and Drug Administration has approved a biosimilar drug made by Teva Pharmaceutical Industries for a condition that results from certain chemotherapy treatments, the drug maker said Thursday.

August 29, 2012

The Food and Drug Administration has approved a supplemental new drug application for an opioid analgesic to treat diabetes-related pain.

August 23, 2012

A drug maker that specializes in pain medications started the third late-stage trial of a drug for treating pain in patients who have undergone certain surgeries.

August 13, 2012

An experimental drug therapy under development by Novartis for liver transplant patients appears to provide similar efficacy and better kidney function, compared with a drug made by Astellas Pharma, according to results of a late-stage clinical trial.

July 27, 2012

Horizon Pharma announced it has received regulatory approval from the Food and Drug Administration for one of its drugs.

July 13, 2012

The Food and Drug Administration has approved a generic contraceptive made by Watson Pharmaceuticals, the drug maker said Friday.

June 28, 2012

Mylan is challenging the patent protection on a Pfizer drug for treating depression, following an announcement of a similar challenge by Watson made earlier this week.

June 25, 2012

The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Monday.

June 14, 2012

Stiefel, a GlaxoSmithKline company, on Monday acquired the eczema remedy Toctino (alitretinoin) from Basilea Pharmaceutica.

June 11, 2012

Avanir Pharmaceuticals confirmed that the Food and Drug Administration has accepted the company's investigational new drug application for an Alzheimer's disease drug.

June 7, 2012

The Food and Drug Administration has approved a drug made by GlaxoSmithKline and XenoPort for treating pain associated with shingles.

June 5, 2012

The Food and Drug Administration has approved a new dosage of an antibiotic drug made by Lupin Pharmaceuticals, Lupin said Tuesday.

April 27, 2012

A drug made by Novartis has received approval from the Food and Drug Administration to treat benign kidney tumors related to tuberous sclerosis complex.

April 11, 2012

Prasco Labs will market an authorized generic version of a drug used to treat diarrhea caused by a bacterial infection, the company said Wednesday.

April 6, 2012

A panel of Food and Drug Administration experts has recommended approval for a drug made by Astellas Pharma for overactive bladder.

March 27, 2012

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating HIV in children.

February 23, 2012

The Food and Drug Administration has accepted a new drug application for the treatment of idiopathic Parkinson’s disease.

February 17, 2012

The Food and Drug Administration has approved a drug made by Merck for Type 2 diabetes, the drug maker said. Merck announced the approval of Janumet XR (sitagliptin and metformin hydrochloride) extended-release tablets as a once-daily treatment for the disease.


January 31, 2012

The Food and Drug Administration has approved a drug made by Vertex Pharmaceuticals for treating a rare form of cystic fibrosis, the agency said Tuesday.

January 25, 2012

The Food and Drug Administration has approved a topical treatment made by Leo Pharma for a skin condition that can lead to cancer, the drug maker said Wednesday.

January 23, 2012

The Food and Drug Administration is streamlining the enrollment process for risk evaluation and mitigation strategies for a class of painkillers, the agency said.

January 6, 2012

The Food and Drug Administration has granted fast-track designation to a drug currently under development by Achillion Pharmaceuticals for hepatitis C, the company said.

January 3, 2012

The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.

December 21, 2011

The Food and Drug Administration has approved an HIV drug for children and adolescents, the agency said Wednesday.

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