Takeda Pharmaceutical Co, Japan´s biggest drugmaker, said the U.S. Food and Drug Administration (FDA) had pushed back the deadline for possible approval of TAK-390MR, a potential successor to its Prevacid ulcer drug, by three months to January 31st, due to examination delays but not to any problem with the drug.

The U.S. patent on Prevacid will expire next year.

Takeda also said it would beat its first half profit forecast on strong sales and a softer-than-expected yen, and it unveiled plans to buy back up to $ 492 million dollars worth of its own shares, equal to 1.35 percent of all stock outstanding.

U.S. regulators have missed their target dates for assessing a string of drug candidates recently and have blamed staff shortages for slowing the review process.

Earlier this month Takeda said U.S. authorities had not been able to complete on schedule a review of diabetes candidate alogliptin or SYR-322, due to a lack of resources.

SYR-322 and TAK-390MR are two of Takeda´s biggest drug candidates on which it is banking to counter likely sales drops in its two best-sellers, the Actos diabetes drug and Prevacid. Actos will lose U.S. patent protection in 2011.

The company is due to announce its first half results on November 4th.