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Wyeth rescues Protonix, but FDA not happy with Pristiq

Wyeth and Nycomed say that a US District Court has accepted their motion to prevent Teva and Sun Pharma launching generic versions of antacid Protonix

US-headquartered Wyeth and its business partner Nycomed have said that the US District Court for New Jersey has accepted their motion for a preliminary injunction against Teva USA and Sun Pharma USA over a potential launch of a generic version of its nocturnal antacid Protonix (pantoprazole).

The court obtained an agreement from Teva and Sun not to launch generic versions of pantoprazole before 7 September 2007, while it considers Wyeth's claims.

Under the Hatch-Waxman act, the filing of the lawsuit stayed final FDA approval of Teva's ANDA until 2 August and Sun's ANDA until 8 September. Wyeth and Nycomed filed a motion for preliminary injunction to stop any potential launch.

Protonix is Wyeth's third best-selling drug and had Sun and Teva succeeded, the introduction of generic copycats would have caused prices to drop by around 80 per cent. The FDA may give final approval to Teva and Sun's applications to sell generic Protonix by 8 September, according to a statement release by Wyeth in June 2007.

Pristiq for menopause sent back for more safety data
In other news, Wyeth has said that the FDA's decision to require a new study of its non-hormonal menopause drug, Pristiq (desvenlafaxine), should not delay its approval as a treatment for depression.

The FDA said on 16 July that it wanted more data on Pristiq's effects on the heart and liver, because in one of Wyeth's four studies in post-menopausal women, two in the group taking Pristiq had heart attacks and three needed procedures to repair clogged arteries, compared with none in the group taking a placebo.

Wyeth countered by revealing that there were eight times as many women taking Pristiq as those on placebo in that study. Also, five women with heart complications had long-standing heart disease.

The request means that Wyeth may not be able to reapply for approval of Pristiq as a menopause drug for about 18 months. The FDA will then have about six months to review the new data and reach a decision.

1st August 2007

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