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Latest zolpidem Stories

2011-09-14 15:05:00

POINT RICHMOND, Calif., Sept. 14, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today its plan to resubmit to the U.S. Food and Drug Administration (FDA) its New Drug Application (NDA) seeking approval of Intermezzo® (zolpidem tartrate sublingual tablet) for use as-needed for the treatment of insomnia when a middle of the night awakening is followed by difficulty returning to sleep. The plan to resubmit the Intermezzo®...

2011-09-13 21:23:00

POINT RICHMOND, Calif., Sept. 13, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) received notice today from the U.S. Food and Drug Administration (FDA) that it generally agrees with Transcept proposals to address concerns raised by the FDA in its July 2011 Intermezzo® Complete Response Letter. As previously announced, Transcept plans to meet with the FDA on September 14, 2011 to discuss the regulatory path forward for Intermezzo®,...

2011-07-25 01:00:00

MISSISSAUGA, Ontario, July 25, 2011 /PRNewswire/ -- Valeant Pharmaceuticals International, Inc. (NYSE: VRX and TSX: VRX) announced that its wholly owned subsidiary, Valeant Canada Limited, has received notice that the New Drug Submission for Sublinox has been approved from the Canadian regulatory authority Health Canada. Sublinox (zolpidem tartrate) is indicated for the short-term treatment and symptomatic relief of insomnia characterized by difficulty in falling asleep, frequent...

2011-07-15 19:02:00

POINT RICHMOND, Calif., July 15, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today plans to reduce operating expenses by eliminating approximately 45% of its workforce following notification from the U.S. Food and Drug Administration (FDA) that the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet), the company's lead product candidate, cannot be approved in its present form....

2011-07-14 22:42:00

POINT RICHMOND, Calif., July 14, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that it has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet). In the Complete Response Letter, the FDA confirmed that Transcept has adequately demonstrated that Intermezzo® is efficacious for use...

2011-07-12 19:02:00

POINT RICHMOND, Calif., July 12, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT) announced today that it expects to receive a Complete Response Letter from the U.S. Food and Drug Administration (FDA) regarding the resubmitted New Drug Application (NDA) for Intermezzo® (zolpidem tartrate sublingual tablet) on or before July 14, 2011, the PDUFA date assigned by the FDA for completion of the Intermezzo® NDA review. The FDA issues a...

2011-06-06 16:00:00

MORRISTOWN, N.J., June 6, 2011 /PRNewswire/ -- Actavis, an international generic pharmaceuticals company, today announced that it has received final approval from the US Food & Drug Administration to market Zolpidem Tartrate Extended-Release Tablets USP, 12.5 mg CIV. Distribution of the product has commenced. Actavis was the first company to launch Zolpidem Tartrate Extended-Release Tablets 6.25 mg strength in October 2010 with 180-day exclusivity. Zolpidem Tartrate...

2011-05-05 15:35:00

POINT RICHMOND, Calif., May 5, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that the company will host a conference call on Monday, May 16, 2011 at 4:30 p.m. Eastern Time to discuss its first quarter 2011 financial results. The conference call will follow the release of the...

2011-03-09 07:02:00

POINT RICHMOND, Calif., March 9, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that the company will host a conference call on Wednesday, March 16, 2011 at 4:30 p.m. Eastern Time to discuss its fourth quarter and full year 2010 financial results. The conference call will...

2011-02-08 15:05:00

POINT RICHMOND, Calif., Feb. 8, 2011 /PRNewswire/ -- Transcept Pharmaceuticals, Inc. (Nasdaq: TSPT), a specialty pharmaceutical company focused on the development and commercialization of proprietary products that address important therapeutic needs in the field of neuroscience, today announced that Transcept management is scheduled to present a general business overview at the BIO CEO & Investor Conference in New York on February 15, 2011 at 3:30 p.m. EST. A live audio webcast and...