Content about Food and Drug Administration

December 13, 2012
GSK's Alli, celebrity Samantha Harris team up to battle the bulge this holiday

GlaxoSmithKline Consumer Healthcare and TV personality Samantha Harris have teamed up to announce the launch of "Let's Fight Holiday Fat" — a new, free online guide that provides weight maintenance support for Americans trying to squeeze in healthy eating and exercise this season.

December 12, 2012
FDA accepts application for Takeda, Lundbeck antidepressant

The Food and Drug Administration has accepted a regulatory approval application from Takeda and Lundbeck for an experimental drug to treat depression, the companies said Wednesday.

December 12, 2012
J&J subsidiary seeks approval for Type 2 diabetes drug

A subsidiary of Johnson & Johnson is seeking regulatory approval for a new Type 2 diabetes drug.

December 12, 2012
NABP implements nationwide effort to oversee compounding pharmacies

A national group representing state boards of pharmacy has announced its support for efforts to strengthen regulations on compounding pharmacies.

December 11, 2012
FDA grants additional market exclusivity to Eisai GERD drug

The Food and Drug Administration is allowing a drug made by Eisai for treating gastroesophageal reflux disease to retain its market exclusivity for six months past the original expiration date, the company said.

December 11, 2012
Reports: SCOTUS to take up branded-generic patent settlements

The Supreme Court will review settlements between branded and generic drug companies that critics say delay patients' access to cheaper drug treatments, according to published reports.

December 10, 2012
FDA approves new indication for J&J prostate cancer drug

The Food and Drug Administration has approved a new use for a cancer drug made by Johnson & Johnson, the agency said Monday.

December 10, 2012
FDA grants Astellas NDA for tacrolimus extended-release capsules

Astellas Pharma US has announced the Food and Drug Administration's approval to review the new drug application for tacrolimus extended-release capsules.

December 10, 2012
Medline promotes use of BioMask facemask to protect against flu

Following last week's news that the influenza season has gotten off to an early start, Medline issued a release recommending the company's BioMask facemask as adequate protection against contracting the flu.

December 10, 2012
Reports: Congressional committee looking into compounding industry group's practices

A Congressional committee is looking into allegations that a compounding pharmacy industry association may have taught pharmacists how to sidestep requests for samples from the Food and Drug Administration, according to published reports.

December 7, 2012
Black holes and gray areas: State, federal authorities take a closer look at pharmacy compounding

Authorities in Massachusetts are looking to tighten regulations on compounding pharmacies as the state health department announced some changes to the makeup of the Massachusetts Board of Pharmacy and sent cease-and-desist notices to three compounding pharmacies for alleged violations.

Retail pharmacies looking to get into sterile compounding and exercise greater control over that supply chain — as Walgreens did last month when it bought an independent specialty compounding pharmacy in Indiana — should take note because it seems there will be increased scrutiny on the practice following a nationwide outbreak of meningitis linked to alleged unsanitary conditions at the Framingham, Mass.-based New England Compounding Center.

December 7, 2012
Mylan launches generic hypertension drug

The Food and Drug Administration has approved a generic hypertension drug made by Mylan, the company said.

December 6, 2012
FDA grants orphan drug designation to Biodel drug for rare insulin disease

The Food and Drug Administration has given special designation to a treatment made by Biodel for patients with congenital hyperinsulinism, a rare disorder that affects children.

December 6, 2012
J&J subsidiary seeks new approval for psoriasis drug

Johnson & Johnson is seeking approval from the Food and Drug Administration for a drug to treat active psoriatic arthritis, the company said Thursday.

December 4, 2012
FDA accepts application for GERD drug in children

The Food and Drug Administration will review an acid-reflux drug made by Eisai for use in children, the drug maker said.

November 30, 2012
FDA approves new medullary thyroid cancer drug

The Food and Drug Administration has approved a new drug made by Exelixis for treating thyroid cancer, the agency said.

November 29, 2012
FDA approves Mylan overactive bladder drug

The Food and Drug Administration approved a new generic drug made by Mylan for urinary disorders, the company said Thursday.

November 29, 2012
FDA panel backs J&J tuberculosis drug

A Food and Drug Administration panel has voted to recommend approval for a Johnson & Johnson drug to treat tuberculosis while the agency has recommended accelerated approval for the drug, the company said.

November 29, 2012
Industry divided over patent settlements

Patent settlements between generic and branded drug companies seem like one of the most controversial and long-standing issues in the pharmaceutical world, with strong opinions on both sides.


November 29, 2012
ReportersNotebook — Over the Counter, 12/10/12

Valeant Consumer Products recently announced that its line of Ocean Saline Nasal Sprays have been the most recommended by pharmacists for 15 years running. 


November 29, 2012
User fee re-authorization 
fuels generics’ outlook

Generic Pharmaceutical Association president and CEO Ralph Neas called it “the most important pharmaceutical legislation since the 1984 Hatch-Waxman Act.” John Castellani, president and CEO of the Pharmaceutical Research and Manufacturers of America, said the law served “the best interests of America’s patients.”


November 28, 2012
Durbin, Blumenthal ask FDA to review energy drinks quickly

Some legislators are concerned with the way energy drinks can affect young consumers.

November 28, 2012
FDA approves Perrigo, Cobrek scalp psoriasis treatment

The Food and Drug Administration has approved a drug from Perrigo and Cobrek Pharmaceuticals for treating scalp conditions.

November 28, 2012
Senators call on FDA to increase oversight of energy drinks

The Food and Drug Administration will review the safety of energy drinks containing such stimulants as caffeine in response to a letter from two senators.

November 27, 2012
Ranbaxy recalls several lots of generic Lipitor

Ranbaxy Labs has recalled more than three dozen lots of its generic version of a cholesterol-lowering statin drug due to the possible presence of foreign particles, the company said.

© 2013 Drug Store News. All Rights Reserved.