February 29, 2012

The Food and Drug Administration has approved a drug for epilepsy made by Hi-Tech Pharmacal, the drug maker said Wednesday.

February 28, 2012

The Food and Drug Administration on Tuesday announced it will hold a public hearing on March 22 and 23 to discuss how technology can expand which drug products can be switched from prescription to over-the-counter status.

February 28, 2012

The Food and Drug Administration has given priority review to a regulatory application from Johnson & Johnson for a drug designed to reduce the risk of complications from internal blood clots.

February 28, 2012

Drugs widely used to treat cholesterol may cause increases in blood sugar and other symptoms, the Food and Drug Administration said Tuesday.

February 27, 2012

The Food and Drug Administration turned down an application for a topical reproductive drug made by Watson Pharmaceuticals and Columbia Labs, the two companies said Monday.

February 27, 2012

A division of specialty pharmacy provider The Apothecary Shops has become the exclusive distributor of a drug used in glaucoma surgery, the company said.

February 24, 2012

Generic drug maker Par Pharmaceutical has completed its acquisition of an Indian drug company, Par said.

February 23, 2012

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

February 23, 2012

The Food and Drug Administration has approved a drug for a rare disorder that previously had no approved medical therapies, the agency said.

February 23, 2012

A panel of experts at the Food and Drug Administration has recommended approval for an obesity drug that so far had not met much success at the agency.

February 23, 2012

The Food and Drug Administration has given tentative approval to a division of Mylan for a generic drug for treating HIV and AIDS in children in developing countries.

February 21, 2012

An executive order from the Obama administration has spurred the Food and Drug Administration to address shortages of two cancer drugs and issue draft guidance for the industry to help prevent future shortages, the agency said Tuesday.

February 21, 2012

The Food and Drug Administration's action to address the ongoing shortage of certain cancer drugs has garnered praise from a group representing the manufacturers and distributors of generic pharmaceuticals.

February 21, 2012

Sen. Charles Schumer on Tuesday announced that the Food and Drug Administration has agreed to conduct a full review of the safety and legality of the new caffeine inhaler AeroShot, distributed by Breathable Foods, which hit stores in New York and Boston this past month.

February 17, 2012

Asthma has been becoming more relevant in the nonprescription aisles of late.

February 17, 2012

A specialty pharmacy provider has begun selling a drug made by Pfizer for treating kidney cancer.

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.


February 15, 2012

Fake versions of a cancer drug made by Roche's U.S. unit have entered the United States, the Food and Drug Administration warned Wednesday.

February 15, 2012

The Food and Drug Administration will review a regulatory approval application from Pfizer for a drug to treat an extremely rare and fatal degenerative disease, Pfizer said Wednesday.

February 14, 2012

The Food and Drug Administration is giving priority review to a drug made by Gilead Sciences that the company is investigating for the prevention of HIV.

February 13, 2012

Amylin Pharmaceuticals and Alkermes announced that their Type 2 diabetes treatment now is available by prescription in U.S. pharmacies.

February 13, 2012

The Food and Drug Administration has approved a Merck drug designed to reduce elevated intraocular pressure in patients with certain eye conditions, the company announced.

February 13, 2012

A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

February 10, 2012

An expert panel at the Food and Drug Administration has given a thumbs-down to a drug made by Astex Pharmaceuticals and Eisai for which the two had sought approval as a treatment for leukemia.