Content about Food and Drug Administration

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.

November 27, 2012
Wockhardt receives three FDA approvals

Indian generic drug maker Wockhardt received three new drug approvals from the Food and Drug Administration, agency records show.

November 21, 2012
FDA approves first flu vaccine manufactured by Novartis using cell culture technology

The Food and Drug Administration on Wednesday announced the approval of Novartis' Flucelvax, the first seasonal influenza vaccine licensed in the United States produced using cultured animal cells, instead of fertilized chicken eggs.

November 21, 2012
Minnesota company barred from going to market for violations of drug and dietary supplement regs

Pharmacist’s Ultimate Health of St. Paul, Minn., and its president, Stephen J. Poindexter, have been barred from distributing any "unapproved new drugs" that the company had distributed under the guise that they were dietary supplements.

November 20, 2012
How tough should compounding oversight be?

When considering new, stiffer regulations governing the compounding of medicines in the wake of the meningitis outbreak, tread carefully and don’t throw the baby out with the bathwater.

That’s the message chain pharmacy had for Congress as lawmakers mull new restrictions on drug compounding by pharmacists.

November 19, 2012
FDA approves GSK drug for hepatitis C patients with low platelet counts

The Food and Drug Administration has approved a drug for a condition that can complicate treatment for hepatitis C.

November 15, 2012
Branded generics transform the old into the new

In the classic Arabian Nights tale “Aladdin and the Magic Lamp,” the sorcerer who sold Aladdin the lamp containing the genie attempts to get it back by walking through the town where Aladdin and his wife live disguised as a merchant, trading “new lamps 
for old.” 


November 15, 2012
FDA panel advises against Merck's Oxytrol patch Rx-to-OTC switch application

The Food and Drug Administration's Nonprescription Drugs Advisory Committee on Friday voted against Merck's application to switch its Oxytrol patch from prescription-only to over the counter, citing concerns over use of therapy for an overactive bladder in women without a doctor's intervention.

November 15, 2012
Generic drugs compete in game of differentiation

The year 2012 is coming to an end, and it’s been a big year for 
generic drugs.


November 15, 2012
Generics target specialty pharmacy with biosimilars

Perhaps the iconic scene at the end of Ridley Scott’s 1991 movie “Thelma & Louise” — with Gina Davis’ and Susan Sarandon’s characters hurdling into the Grand Canyon in a green convertible — is a good metaphor for what’s happening in the generic drug industry these days.


November 15, 2012
NABP report: Rogue pharmacies prolific

At some point in their lives, most people learn the old lesson about things that look too good to be true, sometimes by hearing it from others, and other times from 
bad experiences.


November 15, 2012
NewsBytes — Chain Pharmacy, 11/19/12

The Food and Drug Administration has approved a generic drug for leukemia made by a subsidiary of Par Pharmaceutical Cos.


November 14, 2012
FDA wants more oversight of compounding pharmacies

Food and Drug Administration commissioner Margaret Hamburg is asking Congress to give the agency more power to regulate compounding pharmacies amid a national meningitis outbreak linked to a Massachusetts-based compounding pharmacy that has claimed dozens of lives nationwide.

November 13, 2012
FDA approves Mylan pulmonary arterial hypertension drug

The Food and Drug Administration has approved a generic drug made by Mylan for treating pulmonary arterial hypertension, the drug maker said Tuesday.

November 13, 2012
Reports: AMA supports legislation against 'pay-for-delay' deals

The American Medical Association has come out in favor of legislation to stop deals between branded and generic drug makers that critics blame for delaying entry of generics into the market, according to published reports.

November 13, 2012
Study: Graphic, stop-smoking images more effective than cancer-warning text

Health warning labels on cigarette packages that use pictures to show the health consequences of smoking are effective in reaching adult smokers, according to the results of a new study published in the December issue of the American Journal of Preventive Medicine.

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