Trials & Filings
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August 17, 2006
Akorn, Inc. has submitted the first ANDA with the Office of Generic Drugs on behalf of FDC, Ltd. (FDC). The two companies signed a purchase and supply agreement in July 2004. FDC is an Indian manufacturer and marketer of ophthalmic pharmaceutical pro…
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August 14, 2006
Johnson & Johnson subsidiary Centocor, Inc. received extended approval from the FDA for Remicade for inhibiting progression of structural damage and improving physical function in patients with psoriatic arthritis, in addition to reducing signs a…
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August 10, 2006
Cephalon has received a non-approvable letter from the FDA regarding its sNDA for Sparlon Tablets, a proprietary dosage form of modafinil for the treatment of attention-deficit/hyperactivity disorder (ADHD) in children and adolescents. In considerati…
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August 10, 2006
Pharmos Corp. began dosing in a second Phase IIa study of cannabinor (PRS-211,375) for the treatment of pain. The proof-of-concept trial will test for analgesic activity and safety in healthy subjects experiencing capsaicin-induced pain. The study wi…
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August 9, 2006
Millennium's sNDA for Velecade for the treatment of relapsed mantle cell lymphoma (MCL) was granted Priority Review designation by the FDA. MCL is an aggressive, incurable subtype of non-Hodgkin's lymphoma (NHL) for which there is no current standard…
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August 7, 2006
TorreyPines Therapeutics initiated a Phase I trial for NGX426, an oral therapy intended to treat migraine and chronic pain conditions such as neuropathic pain. The double-blind, placebo-controlled, single ascending dose study, will evaluate the safet…
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August 4, 2006
PDL BioPharma's Phase III study of terlipressin, a vasoactive peptide, did not meet its primary endpoint in the treatment of type 1 hepatorenal syndrome (HRS), a life-threatening complication of advanced liver disease characterized by kidney failure.…
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August 1, 2006
Barr Laboratories, Inc., a subsidiary of Barr Pharmaceuticals, Inc., received final approval from the FDA for its application to manufacture and market a generic version of Pfizer's Xanax XR (Alprazolam Extended-Release) Tablets, 0.5 mg, 1 mg, 2 mg a…
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July 31, 2006
Schering-Plough received approval from the Japan Ministry of Health, Labor and Welfare (MHLW) for Temodal capsules for the treatment of malignant glioma.
The approval follows a priority review of the J-NDA submission, which was g…
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July 31, 2006
Merck's NDA for MK-0431A, an oral medicine combining Januvia with metformin for type 2 diabetes, has been accepted for review by the FDA. The company expects a decision on the NDA by the end of March 2007. The company is also filing for app…
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July 31, 2006
Abbott received FDA approval for Humira for reducing signs and symptoms in patients with active ankylosing spondylitis (AS). AS is an autoimmune disease affecting the spine and large peripheral joints that causes inflammatory back pain…
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July 28, 2006
Schering-Plough Corp. received recommendation for approval of Suboxone from the Committee for Medicinal Products for Human Use (CHMP) of the EMEA. Suboxone sublingual tablets are for the substitution treatment of opioid dependence, within a framework…
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July 25, 2006
Enzon Pharmaceuticals received approval from the FDA for its sBLA for Oncaspar, an oncology product for use as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). Onc…
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July 18, 2006
Eli Lilly and Co. received approval from the FDA for Gemzar for use in the treatment of women living with recurrent ovarian cancer. This marks the fourth approval Gemzar has been granted by the FDA.
The approval specifies that Gemzar be used in…
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July 17, 2006
Wyeth Pharmaceuticals, a division of Wyeth, and Progenics Pharmaceuticals have received Fast Track designation from the FDA for their application of the intravenous form of methylnaltrexone, which is being investigated for the treatment of postoperat…
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