By Ransdell Pierson and Jed Seltzer
NEW YORK (Reuters) - U.S. regulators have approved Barr Pharmaceuticals Inc.'s second plant-derived female hormone replacement tablet, an alternative to animal-derived products that have been linked to serious health risks.
Barr spokeswoman Carol Cox said there is no proof the company's new Enjuvia tablets are safer than estrogens made from animal proteins such as Wyeth's Premarin, whose sales have plunged since being linked to stroke and blood clots.
"We can't make a claim for that. Our product gives women another option," Cox said.
Enjuvia was cleared by the U.S. Food and Drug Administration for treatment of moderate to severe symptoms associated with menopause, which typically include hot flashes, vaginal dryness and night sweats.
Many other companies sell over-the-counter plant products that claim to treat menopausal symptoms, including ones containing Wild Mexican yam, black cohosh and soy.
Barr said it believes it is the only company that sells plant-derived estrogen products by prescription. FDA approval requires rigorous scrutiny for safety and effectiveness that is not required of the over-the-counter products.
Barr said the FDA had approved Enjuvia tablets containing synthetic estrogens in strengths of 0.625 and 1.25 milligrams. It said it intends to seek future approval for other dosage strengths.
The company has been selling another plant-derived estrogen product by prescription since 1999, Cenestin, which has annual U.S. sales of $50 million.
Barr said Enjuvia contains an additional estrogen ingredient that is not present in Cenestin but is in Premarin. The FDA's approval of Enjuvia gives Barr more of an equal footing with Wyeth in marketing Enjuvia to physicians.
Barr cautioned that because of safety concerns, estrogen and synthetic estrogen products should only be prescribed at the lowest effective dose for the shortest possible duration.
Sales of Wyeth's Premarin, whose estrogen is derived from the urine of pregnant mares, have plunged in the past two years after a large, long-term federal study linked it to stroke and blood clots.
Shares of Barr were up $1.31, or 3 percent, to $44.45 in morning trade on the New York Stock Exchange.
Barr, based in Woodcliff Lake, New Jersey, suffered a major defeat last week when the FDA rejected its application to sell Plan B, a "morning-after" contraceptive, without a prescription.
The FDA acted against the recommendations of its advisory panel of independent expert doctors, which had strongly supported approval of Plan B. It was one of the rare occasions when the FDA spurned the advice of such an advisory panel.