Content about Food and Drug Administration

June 26, 2013

Mylan has launched a generic version of a Johnson & Johnson contraceptive, the company said Wednesday.

June 25, 2013

The Food and Drug Administration has given special designation to a drug made by Raptor Pharmaceuticals for a rare metabolic disease.

June 25, 2013

The Food and Drug Administration is allowing the marketing of two new tobacco products under regulations that allow tobacco companies to market products if they can prove they are similar enough to ones already on the market.

June 25, 2013

Drug makers may be allowed to seek approval for a generic version of an eye drug made by Allergan based on lab tests rather than clinical trials, according to published reports.

June 25, 2013

Takeda Pharmaceutical Co. is seeking Food and Drug Administration approval for an experimental treatment for inflammatory bowel disease, the drug maker said.

June 24, 2013

The Consumer Healthcare Products Association board of directors on Friday approved voluntary labeling guidelines for caffeine-containing dietary supplements discussed during the June 18 board meeting.

June 24, 2013

The National Association of Chain Drug Stores has promoted Kevin Nicholson to the new position of VP public policy and regulatory affairs, effective Monday.

June 24, 2013

Generic drug makers cannot be held liable if patients suffer harmful side effects after taking their drugs, the Supreme Court has ruled in a 5-4 decision.

June 21, 2013

The Food and Drug Administration has approved a contraceptive pill for all women of childbearing potential without a prescription, the agency said.

June 20, 2013

Tris Pharma has hired a former buyer from AmerisourceBergen to head its generic drug business, the company said.

June 18, 2013

The Food and Drug Administration's Center for Drug Evaluation and Research has collected 84% of the fees it intends to collect this year under a law passed last year to collect user fees from generic drug members, according to a memo sent out to CDER staff Tuesday.

June 17, 2013

Patent settlements between brand and generic drug makers commonly referred to as "pay-for-delay" settlements are not necessarily against the law, the Supreme Court ruled Monday.

June 13, 2013

The Food and Drug Administration has approved a drug made by Amgen for treating a rare and usually noncancerous bone tumor, the agency said Thursday.

June 11, 2013

The emergency contraceptive Plan B (the original two-tablet formulation) can now be sold as an OTC without any sales restrictions as the Obama administration concedes its fight to prevent nonprescription access to younger teenage girls. And soon the newer Plan B One Step (one tablet) will be available without sales restrictions as well.

June 10, 2013

A 26-member joint panel comprising the Food and Drug Administration's Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management advisory committees voted to support modifying or removing the risk evaluation and mitigation strategy protocol for GlaxoSmithKline's Type 2 diabetes drug Avandia (rosiglitazone).

Historically, the FDA has followed advisory committee votes when making a decision on the marketing of a drug even though it is not bound by them, but assuming the agency follows the panel's advice, it could mean a lot for the controversial drug and the way it's dispensed. But even if Avandia winds up on retail pharmacy shelves again, it faces a very different landscape from its heyday.

June 7, 2013

Actavis is hoping to become the first to market generic versions of a contraceptive and a sedative, the drug maker said.

June 7, 2013

A joint Food and Drug Administration expert panel voted to recommend keeping a controversial GlaxoSmithKline diabetes drug available for certain patients, GSK said.

June 7, 2013

The Council for Responsible Nutrition strongly criticized the Center for Science in the Public Interest earlier this week as that organization petitioned the Food and Drug Administration to prohibit the sale of Ginkgo biloba.

June 6, 2013

The Food and Drug Administration has approved a drug made by Celgene for treating a type of cancer.

June 5, 2013

South Korean drug maker Hanmi Pharmaceutical Co. and U.S. partner Amneal Pharmaceuticals have made an agreement in federal court concerning a generic heartburn drug.

May 30, 2013

Beauty trends are as much a reflection of the consumer's state of mind as they are a reflection of the technological innovations put forth by research-and-development teams at laboratories around the world. While consumers are not able to verbalize their expectations for the ideal product that will fulfill their needs, they are able to pinpoint gaps with their unmet needs through their purchasing patterns.

May 30, 2013

This summer, the Supreme Court will decide on a case that could determine whether generic drug makers can be held liable when patients suffer harmful side effects from taking their drugs.

May 30, 2013

The Food and Drug Administration last month announced that it has approved an amended application submitted by Teva Women's Health to market Plan B One-Step (levonorgestrel) for use without a prescription by women 15 years of age and older. That approval moved Plan B One-Step from behind the pharmacy counter into the family planning section of the pharmacy.

May 30, 2013

The year is only halfway done, but 2013 is already proving to be a year of particular importance for generic drugs as the industry awaits two important decisions from the Supreme Court and continues to wait for federal biosimilar regulations while fending off efforts to limit the scope of their use at the state level.

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