Shares of
plummeted Thursday evening after the company said federal regulators pushed back the target date to review the company’s treatment for gout.
Savient said in a statement the Food and Drug Administration has extended its review for the drug by three months until July 30. FDA also notified the company it will likely reschedule a meeting planned for March 5 to review the company’s drug.
Savient has asked the FDA to approve the injectable Read the rest of this entry »

The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with
gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda
Pharmaceuticals North America is the sole developer and marketer of the product in the US.
According to a statement from Takeda, febuxostat is a new highly potent Read the rest of this entry »

For the first time in more than forty years there’s a new medication receiving FDA approval for the treatment of gout. 
That often affects one joint, which is most often the big toe, but can happen with many joints in the body.
It’s the most common inflammatory arthritis is men over age 40.
The medicine is called Uloric.
It’s a once daily oral medication that works by blocking an enzyme which helps prevent uric acid production, lowering uric Read the rest of this entry »

(RTTNews) - 
Savient Pharmaceuticals, Inc. (SVNT:
) Thursday said that the US Food and Drug administration has extended the review period of the company’s gout drug by three months to July 30, 2009, following the submission of a major amendment to the previously submitted Biologics License Application, which was granted priority review. Following the news, Savient shares plunged more than 25%, in after-hour trading, Read the rest of this entry »

NEW YORK (Reuters) – New data do not signal any heart risks with Takeda Pharmaceutical Co Ltd’s experimental drug to treat acid build-up in patients with gout, a top U.S. Food and Drug Administration official said in a document released on Thursday.
Takeda is seeking U.S. approval to sell its drug febuxostat for chronic gout patients with hyperuricemia, a build up of uric acid that can lead to swollen joints and arthritis flare-ups. The company Read the rest of this entry »

The U.S. Food and Drug Administration has approved the first new prescription for gout in four decades, providing a boost to a Deerfield-based drug maker.
Takeda Pharmaceuticals North America Inc. said Friday night that its Uloric drug is another treatment option for the more than 5 million Americans who suffer from gout, which is characterized by intense pain, inflammation and warmth in the affected joints.
“We are pleased to offer a new treatment Read the rest of this entry »

Teijin Pharma and Takeda Pharmaceutical Company have announced that Teijin Pharma’s US licensee for febuxostat and Takeda’s wholly owned subsidiary, Takeda Pharmaceuticals North America, has received the FDA’s marketing approval for Uloric for the chronic management of hyperuricemia in patients with gout.
According to Teijin Pharma, febuxostat is an oral, once-daily, novel highly potent non-purine selective inhibitor of xanthine oxidase, having Read the rest of this entry »

The FDA has approved the first medical treatment in 40 years for gout. Uloric has been developed and will be marketed by Takeda Pharmaceuticals North America. Uloric will be available by prescription in strengths of 40 or 80 mg pills to be taken by mouth once daily.
Over the last 40 years, Allopurinol had been prescribed for gout. Doctors were concerned and hesitant to prescribe Allopurinol due to side effects. Patients, in some cases, would report Read the rest of this entry »

Nov. 24, 2008 — Uloric should be the first new
drug to be approved in over 40 years, an FDA
expert panel recommends.
Currently, allopurinol (trade name, Zyloprim) is the only FDA-approved drug
that prevents formation of the uric acid crystals that cause gout. However,
side effects — including potentially fatal reactions — limit the amount of
allopurinol that can be tolerated. Most gout patients do not receive fully
effective doses of allopurinol.
Read the rest of this entry »

(Adds details from panel, byline)
SILVER SPRING, Md., Nov 24 (Reuters) – The U.S. Food and
Drug Administration should approve Takeda Pharmaceutical Co
Ltd’s (4502.T:
,
,
,
) experimental gout drug as long as the agency
requires further safety studies, an FDA advisory panel said on
Monday.
The Japanese drugmaker is seeking U.S. approval to market
its drug febuxostat under the brand name Uloric, which if
approved, would be the first new Read the rest of this entry »