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Latest gabapentin Stories

2009-01-09 07:30:00

LONDON, RESEARCH TRIANGLE PARK, N.C. and SANTA CLARA, Calif., Jan. 9 /PRNewswire-FirstCall/ -- GlaxoSmithKline and XenoPort, Inc. announced today that GSK has resubmitted the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) requesting approval of Solzira(TM) (gabapentin enacarbil) Extended Release Tablets for the treatment of moderate-to-severe primary Restless Legs Syndrome (RLS). The FDA had requested that the data in a single study be reformatted. In addition,...

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2008-12-17 08:35:00

The drugs that cure epileptic seizures are known to increase the risk of suicide, and federal regulators decided Tuesday drug companies must clearly display that warning.The Food and Drug Administration made the announcement a year after the agency first said patients taking the drugs have a slightly higher risk for suicide than those taking dummy pills.One in 500 patients face an increased risk of suicidal thoughts and behavior while taking the drugs. The new warning emphasizes that risks...

2008-12-16 14:56:47

The U.S. Food and Drug Administration says it will require suicide warnings on all anti-epileptic drugs, including those used to treat other conditions. The federal agency says the warning about the risk of suicidal thoughts and suicidality will be required on all anti-epileptic drugs that are also used to treat psychiatric disorders, migraine headaches and other conditions. The warnings will appear on all prescribing information or labeling. Patients being treated with anti-epileptic drugs...

2008-11-07 15:00:21

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Court of Appeals for the Federal Circuit has affirmed a March 31, 2008 decision by the District Court, which had found TAP Pharmaceutical Products Inc.'s U.S. Patent No. 4,628,098 valid and enforceable. As a result of today's decision, Teva expects to market its generic version of TAP's Prevacid(R) (Lansoprazole) Delayed Release Capsules, 15 mg and 30 mg no later than November 10, 2009, when the patent is...

2008-11-03 15:00:21

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) today announced results of a study in which Azilect(R) (rasagiline tablets) demonstrated selective MAO-B inhibition at the approved dose of 1mg. Non selective MAO inhibitors may have some contra indications with certain foods and drugs. These limitations are not associated with selective MAO inhibitors and therefore they can be broadly prescribed. Based on these positive results, Teva will work with the U.S. Food and Drug Administration...

2008-10-27 06:00:23

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) announced today that it has entered into a settlement agreement with an institution that acted as a broker in placing investments in Teva's portfolio of auction rate securities. In consideration for a full release of the institution, Teva has received a cash payment of $100 million. Due to confidentially restrictions, additional information will not be disclosed. Teva will record this payment as one time finance income and will exclude...

2008-10-20 06:00:22

Depomed, Inc. (NASDAQ:DEPO) announced today the enrollment and dosing of the first patient in Breeze 2, the second of two pivotal Phase 3 clinical trials in Depomed's registration program for DM-5689 (formerly referred to as Gabapentin GR(R)) for the treatment of menopausal hot flashes. Breeze 1, the first Phase 3 clinical trial, was initiated in September. "I look forward to the results of Depomed's Phase 3 trials for DM-5689 in menopausal hot flashes after having seen Depomed's...

2008-10-16 06:00:31

Depomed, Inc. (NASDAQ:DEPO) today announced that it will release third quarter financial results for 2008 after the market closes on Thursday, October 30, 2008. The company will webcast a conference call beginning at 5:00 p.m. ET, 2:00 p.m. PT to discuss its results and to provide an update and future outlook on company events. Interested parties can access the live and archived broadcast of the call at www.depomedinc.com. About Depomed Depomed, Inc. is a specialty...

2008-10-16 03:00:19

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has entered into a definitive agreement to sell its Israeli based veterinary business unit to Phibro Animal Health Corporation, for total consideration of approximately $47 million. The transaction is subject to certain conditions, including Israeli antitrust approvals and other closing conditions, and is expected to close in the first quarter of 2009. Teva's veterinary business unit in Israel develops,...

2008-09-25 17:46:23

Depomed, Inc. (Nasdaq:DEPO) today announced the presentation of data from its Phase 2 study of DM-5689 (formerly referred to as Gabapentin GR(R)) for the treatment of women with moderate-to-severe menopausal hot flashes. As previously disclosed, DM-5689 significantly reduced the frequency and severity of hot flashes from baseline to the end of treatment compared to placebo in the 124 patient study. The data were presented today at the North American Menopause Society (NAMS) Annual...


Word of the Day
jument
  • A beast of burden; also, a beast in general.
'Jument' ultimately comes from the Latin 'jugum,' yoke.
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