The FDA has recalled more than 13,000 bottles of metoprolol succinate extended release tablets manufactured by Dr. Reddy’s Laboratories. Two months ago the agency recalled another lot of generic metoprolol from a different company, Wockhardt. Both recalls were for medicines manufactured at facilities in India. There have been multiple reports in recent years of problems with generic drugs made in India.
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Ranbaxy, the often-troubled manufacturer of generic drugs, will temporarily stop manufacturing generic atorvastatin. On November 9, 2012 the company announced a voluntary recall of some lots of atorvastatin because of possible contamination with glass particles. An FDA statement today said that Ranbaxy will discontinue making the drug “until it has thoroughly investigated the cause of the glass particulates and remedied the problem.”
To date, no reports of harm from the contamination have been received by the FDA. Both FDA and Ranbaxy believe there is only a low likelihood that there will be adverse events related to the problem.
The FDA said it does not anticipate a shortage of atorvastatin because of the recall, but that it “is working with other manufacturers of atorvastatin to ensure adequate market supply.”
Click to read the FDA statement…
Although the patent on valsartan (Diovan, Novartis) expired last Friday, a generic version of the popular antihypertensive drug has yet to make it to market. By contrast, a generic version of Diovan HCT, the combination of valsartan and hydrochlorothiazide, was recently launched by generic drugmaker Mylan.
As reported on Pharmalot, Ranbaxy, the embattled generic drugmaker, holds the exclusive rights to market generic valsartan for 180 days, but has so far been unable to gain FDA approval. The delay, according to Pharmalot, “only adds to the uncertainty surrounding Ranbaxy’s ability to recover from its long-standing manufacturing woes and haggling with the FDA over its ability to resume operations on regular basis in the US.”
According to the Wall Street Journal, the Diovan franchise generated $5.7 billion worldwide in 2011.
Click here to read the Mylan press release…
For the second time in the past six months, a cardiology mainstay drug has lost patent protection and gone generic. Today the FDA announced that it had approved several generic versions of clopidogrel (Plavix), the antiplatelet drug that for many years was the second best-selling drug in the world. Last November the best-selling drug of all time, Lipitor (atorvastatin), another cardiology mainstay, went off patent, though it wasn’t until earlier this month that multiple generics became available.
The FDA said that it had approved 300 mg formulations of clopdiogrel from Gate Pharmaceuticals, Mylan Pharmaceuticals, and Teva Pharmaceuticals and 75 mg formulations from Apotex Corporation, Aurobindo Pharma, Mylan Pharmaceuticals, Roxane Laboratories, Sun Pharma, Teva Pharmaceuticals, and Torrent Pharmaceuticals.
In recent years the FDA approved two newer antiplatelet drugs that had been designed to take over the central role of Plavix in treating acute coronary syndromes. However, these drugs, prasugrel (Effient) and ticagrelor (Brilinta) have been struggling in the marketplace, and at this point appear very unlikely to command a significant share of the market.
Click here to read the FDA press release…
Pfizer will no longer aggressively market Lipitor (atorvastatin), its former crown jewel and the most lucrative pharmaceutical product ever. At the same time, generic drug manufacturer Ranbaxy posted record revenue for the last business quarter, growth fueled largely by sales of generic atorvastatin in the United States.
Pfizer told the Wall Street Journal that it was abandoning efforts to market Lipitor. It said it was no longer selling Lipitor to health plans, that it had stopped using drug reps to promote the drug to physicians, and that it had ceased all Lipitor advertising. The Pfizer move comes after the expiration of the Lipitor patent last fall but immediately prior to May 31, when a host of new generic versions of atorvastatin are expected to enter the marketplace.
Pfizer mounted an aggressive campaign to retain as much of the atorvastatin market as possible in the early days after the loss of market exclusivity. In the first quarter, according to the Journal, Lipitor revenues for Pfizer were $383 million. This was more than most analysts had originally anticipated, until Pfizer rolled out its aggressive campaign, but paled in comparison to the $12.9 billion annual sales of the drug at its peak. Pfizer said it had spent $87 million marketing Lipitor in the quarter.
Also in the first quarter, Ranbaxy sales in the US doubled to $375 million. This was the first full quarter in which the company sold generic atorvastatin. In March, for the first time, Ranbaxy had a greater share of the atorvastatin market than Pfizer, according to Fierce Pharma.