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FDA Approves AstraZeneca’s SEROQUEL XR(R) for the Treatment of Bipolar Depression and Bipolar Mania
WILMINGTON, Del., Oct. 10 — AstraZeneca (NYSE:
AZN) today announced that the U.S. Food and Drug Administration (FDA) has
approved once-daily SEROQUEL XR(R) (quetiapine fumarate) Extended-Release
Tablets for the acute treatment of the depressive episodes associated with
bipolar disorder, the manic and mixed episodes associated with bipolar I
disorder, and the maintenance treatment of bipolar I [...]
AstraZeneca Receives Six Months Pediatric Exclusivity for CASODEX(R) (bicalutamide) from the FD
WILMINGTON, Del., Sept. 22 – AstraZeneca today
announced that the United States Food and Drug Administration (FDA) has
granted an additional six-month period of exclusivity to market CASODEX(R)
(bicalutamide) for its licensed advanced prostate cancer indication until
April 1, 2009. AstraZeneca has been working with the FDA in the
investigation of the safety and effectiveness of CASODEX in a pediatric
setting [...]
New Study Suggests Increasing Prescription Co-payments for Chronic Diseases May Worsen Health Disparities, Adversely Affect Health
PHILADELPHIA, Aug. 19 – The relationship
between medication adherence and income level may contribute to the
disparities in health observed across socioeconomic groups, according to a
recent study published in the Journal of General Internal Medicine. The
study, funded by GlaxoSmithKline (NYSE: GSK), investigated whether
individuals who reside in low-income areas are more strongly influenced by
rising prescription drug co-payments than [...]
New Aptivus(R) (tipranavir) Oral Solution Approved for Treatment-Experienced Pediatric and Adolescent HIV Patients
RIDGEFIELD, Conn., June 24 — Boehringer Ingelheim
Pharmaceuticals, Inc. today announced that the U.S. Food and Drug
Administration (FDA) granted approval of Aptivus(R) (tipranavir)
capsules/oral solution with dosing information for treatment-experienced
pediatric patients between the ages of 2-18 infected with HIV-1. The oral
solution formulation, which is a new dosage form of APTIVUS, was also
approved for treatment-experienced adults. The oral [...]
Mission Pharmacal Launches Ferralet(R) 90 for Treatment of the Leading Cause of Anemia in the U.S.
SAN ANTONIO, May 20 - Mission Pharmacal announced the
launch of Ferralet(R) 90, a new prescription oral iron supplement for
treatment of iron deficiency anemia (IDA) that is responsive to oral iron
therapy. IDA is a depletion of stored iron that prevents maturation of red
blood cells. Ferralet 90 contains 90 mg of carbonyl iron as well as
essential vitamins and [...]
FDA Approves VYVANSE(TM) (lisdexamfetamine dimesylate), the First and Only Once-Daily Prodrug Stimulant to Treat ADHD in Adults
BASINGSTOKE, England and PHILADELPHIA, April 23
- Shire plc (LSE: SHP) (NASDAQ: SHPGY,), the global specialty
biopharmaceutical company, today announced that it has received approval
from the U.S. Food and Drug Administration (FDA) for VYVANSE(TM)
(lisdexamfetamine dimesylate), for the treatment of Attention Deficit
Hyperactivity Disorder (ADHD) in adults. VYVANSE, introduced in July 2007
for the treatment of ADHD in children aged [...]
D-Pharm Completes Pre-IND Meeting With the FDA for Treatment of Acute Stroke With DP-b99
REHOVOT, Israel, March 4 - D-Pharm announced today that
it has held its Pre-IND (Investigational New Drug) meeting with the FDA to
discuss the forthcoming IND submission for DP-b99, a novel drug to aid
recovery following acute stroke. The Pre-IND meeting focused on the
proposed plans for the Phase III clinical program and the discussion
included clinical trials to date, preclinical [...]
AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Major Depressive Disorder
WILMINGTON, Del., Feb. 29 - AstraZeneca (NYSE:
AZN) today announced the submission of a supplemental New Drug Application
(sNDA) to the U.S. Food and Drug Administration (FDA) for once- daily
SEROQUEL XR(TM) (quetiapine fumarate) Extended-Release Tablets to seek
approval for the treatment of major depressive disorder (MDD) as
monotherapy, adjunct therapy, and maintenance therapy in adult patients.
MDD affects 15 million [...]
Alexion Commences Dosing in AEGIS Registration Study of Soliris(R) (eculizumab) in Patients with PNH in Japan
CHESHIRE, Conn., Jan. 7 - Alexion
Pharmaceuticals, Inc. (the “Company,” Nasdaq: ALXN) today announced that it
has commenced dosing in the AEGIS study, a single registration study to
evaluate the safety, efficacy, and pharmacology of Soliris(R) (eculizumab)
as a treatment for Japanese patients with paroxysmal nocturnal
hemoglobinuria (PNH). When fully enrolled, the open-label study, authorized
by Japan’s Pharmaceutical and Medical Device Administration [...]
