Mylan Inc. said today its subsidiary Mylan Laboratories Ltd. received tentative approval from the U.S. Food and Drug Administration for a generic version of Lipitor, one of the most commonly prescribed drugs in the nation.
In a news release, Mylan Inc, said the FDA green lighted its Abbreviated New Drug Application, or ANDA, for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base).
Atorvastatin Calcium is the generic equivalent to Pfizer's Lipitor tablets, which is prescribed to prevent cardiovascular disease and reduce cholesterol levels in patients.
Earlier this week, Pfizer announced its fourth-quarter profits fell by half because it sold less Lipitor, thanks in part to the drug going off patent last year. When Lipitor ceased being protected by patents, it opened the door for generic drug manufacturers, such as Mylan, to start making similar versions of the medication.
According to State Journal research, Lipitor was the 10th most commonly prescribed medicine in West Virginia in 2011.
In a Wall Street Journal article, Pfizer said its lower earnings were softened by cuts in its sales force and other costs. But that didn't keep the drug maker from lowered its 2012 forecast due to the strengthening dollar and bigger-than-expected price cuts in two emerging markets, China and Turkey.
Pfizer, which also make Viagra and numerous other popular pharmaceuticals, said its net income was $1.44 billion, or 19 cents per share, down from $2.89 billion, or 36 cents per share, a year earlier.
The Wall Street Journal reported generic competition to about a dozen drugs reduced revenue 4 percent to $16.75 billion, from $17.35 billion. The story said adjusted income and revenue topped analysts' expectations of 47 cents per share on revenue of $16.61 billion.
Mylan is expected to announce its fourth-quarter and year-end earnings to investors on Feb. 21.
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