August 19, 2014

The Food and Drug Administration has approved Mylan Institutional’s application for its dexmedetomidine hydrochloride injection, the company announced Tuesday. 

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 2, 2014

On June 25, the U.S. Department of Justice, at the request of the Food and Drug Administration, filed a complaint for permanent injunction in the U.S. District Court for the Central District of California against Laclede of Rancho Dominguez, Calif., and its president, Michael Pellico.

June 26, 2014

The Food and Drug Administration has issued a warning that certain OTC topical acne products may cause rare but serious and potentially life-threatening allergic reactions or severe irritation.

June 2, 2014

Mylan announced on Monday that it has entered into a settlement and license agreement with Pfizer relating to Mylan's abbreviated new drug application filed with the U.S. Food and Drug Administration for celecoxib capsules in 50-mg, 100-mg, 200-mg and 400-mg strengths.

March 25, 2014

The Drug Store News Group, the leading provider of news, information and clinical education for the retail pharmacy industry, has launched the new microsite, Drugstorenews.com/pain-management, to help bring attention to another tragic side of the prescription drug abuse story — the millions of Americans who live in chronic pain that may be unable to access the medications they need thanks to proposed changes in regulatory policy.

March 12, 2014

Upsher-Smith has received approval from the Food and Drug Administration for Qudexy XR (topiramate) extended-release capsules, a once-daily, broad-spectrum antiepileptic drug specifically engineered to deliver a smooth pharmacokinetic profile.

February 28, 2014

The Council for Responsible Nutrition on Friday welcomed news of the U.S. Food and Drug Administration’s proposed rule, “Food Labeling: Revision of the Nutrition and Supplement Facts Labels.”

January 24, 2014

Perrigo announced that it received final approval from the Food and Drug Administration for repaglinide tablets — a generic version of Prandin tablets.

January 17, 2014

Nuvo Research on Friday announced that the U.S. Food and Drug Administration approved Mallinckrodt's new drug application for Pennsaid (diclofenac sodium topical solution) 2%

January 16, 2014

Merck on Wednesday commended the U.S. Food and Drug Administration’s Cardiovascular and Renal Drugs Advisory Committee’s recommendation for approval of vorapaxar.

September 10, 2013

While the U.S. generic drug market has grown at a rapid pace, the international market for generic manufacturing and use has grown as well.

August 13, 2013

The Food and Drug Administration approved Tivicay (dolutegravir), a new drug to treat HIV-1 infection that is manufactured by GlaxoSmithKline.

August 13, 2013

The U.S. Food and Drug Administration this past weekend announced new fee rates for fiscal year 2014, including the abbreviated new drug application fee.

August 13, 2013

Lundbeck announced today that Onfi (clobazam) CIV will be available in scored tablet and oral suspension formulations beginning this week after the formulations were recently approved by the Food and Drug Administration.

August 12, 2013

Perrigo Co. announced that it has received final approval from the Food and Drug Administration for its abbreviated new drug applications for fluocinolone acetonide scalp oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Scalp Oil, and fluocinolone acetonide topical oil, 0.01%, the generic equivalent to Derma-Smoothe/FS Body Oil.

August 8, 2013

Eisai announced that the Food and Drug Administration has granted orphan drug designation to its investigational compound (E7777) for cutaneous T-cell lymphoma.

August 8, 2013

Keryx Biopharmaceuticals announced the submission of a new drug application to the Food and Drug Administration seeking approval for the marketing and sale of Zerenex (ferric citrate coordination complex), the company's drug candidate for the treatment of elevated serum phosphorus levels, or hyperphosphatemia, in patients with chronic kidney disease on dialysis.

May 17, 2013

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 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

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

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

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

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.