Content about Pharmaceutical industry

Abusive auditing and unfair reimbursement practices harm community pharmacists’ ability to provide critically needed patient counseling and care to seniors, according to a new survey released Sept. 18 by the National Community Pharmacists Association.


NCPA polled more than 350 community pharmacists about their recent experience with audits conducted by pharmacy benefit managers and other Medicare Part D plan intermediaries. The survey also asked about generic drug reimbursement caps known as maximum allowable costs, or MACs. 


Among the findings:


PRINCETON, N.J. — Ranbaxy Labs has launched an authorized generic drug for treating dry mouth associated with an autoimmune disorder, the company said Tuesday.

The India-based generic drug maker announced the launch of cevimeline hydrochloride in the 30-mg strength under an agreement with parent company Daiichi Sankyo. The drug is used in patients with Sjogren's syndrome, which affects the moisture-producing glands.

PITTSBURGH — Generic drug maker Mylan has received regulatory approval for a drug used to treat high blood pressure, also known as hypertension, the company said Friday, saying that it would launch both drugs immediately.

Mylan said the Food and Drug Administration approved its irbesartan tablets in the 75 mg, 150 mg and 300 mg strengths and irbesartan and hydrochlorothiazide tablets in the 150 mg/12.5 mg and 300 mg/12.5 mg strengths. The drugs are respectively generic versions of Sanofi's Avapro and Avalide.

WHAT IT MEANS AND WHY IT'S IMPORTANT — Sticker shock is often a major factor in any person's purchasing decisions, but while deciding to put off buying a new car might not have catastrophic consequences, not filling a prescription because it costs too much can.

(THE NEWS: Pharmacists say cost is biggest barrier to Rx adherence. Click here to read the story.) 

MENLO PARK, Calif. — A drug maker is suing the Food and Drug Administration to force the agency to give a special designation to one of its drugs.

Depomed announced that it had filed suit against the FDA in federal district court for the District of Columbia seeking an order that would require the agency to grant the drug Gralise (gabapentin) orphan drug exclusivity for the management of post-herpetic neuralgia. The disease, also known as PHN, is a condition causing prolonged pain in people who have had shingles, a complication of chickenpox.

NEW YORK — The generic drug user fee program may have hit a speed bump due to budget problems in Congress, according to published reports.

Bloomberg reported that implementation of the law may be delayed because Congress must first pass legislation authorizing the Food and Drug Administration to collect money from generic drug companies, but the problem is that members of Congress will leave Washington this week, not to return until after the Nov. 6 elections.

It wasn’t that long ago that the branded drug industry was seen as an unstoppable titan of American industry, churning out a steady stream of breakthrough therapies and blockbuster products. But a tsunami of expiring patents on such top selling drugs as Lipitor, Plavix and Seroquel, combined with a slowdown in research and development, flattened the growth curve in recent years and opened the door for the ascendancy of generic drugs.

PHILADELPHIA — The pharmaceuticals business will begin picking up in 2014, AmerisourceBergen president and CEO Steve Collis said last week at the wholesaler's ThinkLive Manufacturer's Summit held here. "Next year is a slower brand-to-generic [trend] and in 2014 we’re going to see a resumption in that top-line growth rate [across the pharmaceutical industry in the U.S.] to a modest 4% growth," Collis said. "That’s not too bad," he added, especially when you compare that growth up against what's happening worldwide.

PITTSBURGH — The Food and Drug Administration has approved a generic drug for motion sickness made by Mylan.

The drug maker announced Friday that the FDA had approved meclizine hydrochloride tablets in the 12.5-mg, 25-mg and 50-mg strengths. Mylan said it would launch the drug immediately.

The drug is a generic version of Pfizer's Antivert, which is used to treat nausea, vomiting and dizziness associated with motion sickness. Antivert had sales of about $53.5 million during the 12-month period ended in June, according to IMS Health.

MARLBOROUGH, Mass. – The Food and Drug Administration has approved a drug made by Acton Pharmaceuticals for asthma, the company said Thursday.

The drug maker announced the approval of Aerospan (flunisolide HFA) inhalation aerosol as a maintenance treatment for asthma in patients aged 6 and older. The drug maker plans to launch the drug in early 2013.

A trillion of anything is difficult to wrap one’s head around, whether it’s the number of grains of sand on a beach or stars in the sky. It’s so much easier for the human mind to look at such a quantity as the sum of its parts rather than on the basis of its individual components.