Posts Tagged ‘pharmaceuticals’
Javelin Pharmaceuticals’ Receives FDA PDUFA Date For Dyloject™ NDA
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV), a leading developer and marketer of specialty pharmaceutical products for pain management, announced that its New Drug Application (NDA) submitted on December 2, 2009 to the US Food and Drug Administration (FDA) for its investigational product candidate, Dyloject™ (diclofenac sodium) Injection, has received an FDA PDUFA date of October 3, 2010…
Third Party Reexamination Of Javelin Pharmaceuticals’ Phase III Trial Data For Ereska Yields Statistically Significant Primary Endpoint
Javelin Pharmaceuticals, Inc. (NYSE Amex: JAV – News) announced that a reexamination conducted by a third party of pain score measurements from its Phase III study of Ereska? (intranasal ketamine) showed that top line results for its primary endpoint were statistically significant…
MAP Pharmaceuticals Announces FDA Will Not Require A Second Pivotal Efficacy Study For LEVADEX(TM) NDA Submission
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the U.S. Food and Drug Administration (FDA) has informed the Company that a second pivotal efficacy study is not required for the Company’s LEVADEX(TM) new drug application (NDA) submission for the acute treatment of migraine…
Cadence Pharmaceuticals Announces FDA Extends New Drug Application Review For Intravenous Acetaminophen By Three Months
Cadence Pharmaceuticals, Inc. (Nasdaq: CADX) announced that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Priority Review of the New Drug Application (NDA) for intravenous (IV) acetaminophen by three months. The extended PDUFA goal date is February 12, 2010.
Transdel Pharmaceuticals Announces Positive Phase 3 Study Results For Lead Topical Pain Drug Ketotransdel(R)
Transdel Pharmaceuticals, Inc. (OTC Bulletin Board: TDLP), a specialty pharmaceutical company focused on developing topically administered products using its proprietary transdermal delivery platform, today announced positive top-line clinical results for its lead pain drug Ketotransdel®( )in a Phase 3 trial which evaluated the efficacy and safety of the drug in acute soft tissue injuries of the upper and lower extremities.
Biostar Pharmaceuticals, Inc. Receives The Chinese Military Drug Administration Clearance To Begin Clinical Trial For Zushima Analgesic Aerosol Spray
Biostar Pharmaceuticals, Inc. (OTC Bulletin Board: BSPM) (“Biostar” or “the Company”), a Xianyang-based developer, manufacturer and supplier of pharmaceutical products and medical nutrients addressing a variety of diseases and conditions announced that the Chinese Military Drug Administration has granted clearance to begin clinical trials on the Company’s new drug application, the Zushima Analgesic Aerosol Spray.
APP Pharmaceuticals Receives Approval For Sumatriptan Succinate Injection, USP
APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., (NASDAQ: APCVZ) announced today that it has received approval from the U.S. Food and Drug Administration (FDA) to market Sumatriptan Succinate Injection, USP, in two dosage strengths. Sumatriptan Succinate Injection is therapeutically equivalent to the reference-listed drug Imitrex®, which is marketed by the innovator GlaxoSmithKline.
JHP Pharmaceuticals Introduces A Dantrium(R) IV (dantrolene Sodium For Injection), Rapidly Mixing At 20 Seconds
JHP Pharmaceuticals, LLC (“JHP”) announced that it had developed, and received approval by the FDA for Dantrium® IV (dantrolene sodium for injection), a rapidly mixing product. Dantrium® IV now reconstitutes in approximately 20 seconds, which is 4 times faster than before, saving valuable time and effort during a malignant hyperthermia (MH) emergency.
Valeant Pharmaceuticals Announces Preliminary Results From Its Phase IIa Retigabine Study For The Treatment Of Postherpetic Neuralgia (PHN)
Valeant Pharmaceuticals International (NYSE: VRX) announced preliminary results from its Phase IIa proof-of-concept clinical trial of retigabine for the treatment of pain associated with postherpetic neuralgia (PHN), a painful and common complication of shingles. While retigabine was generally well tolerated, the study did not meet its pre-specified primary efficacy endpoint. Further detailed analyses are warranted and are ongoing.
BioSante Pharmaceuticals Reports 100% Protection From H1N1 Challenge When Using BioVant? Adjuvanted Vaccine
BioSante Pharmaceuticals, Inc. (NASDAQ: BPAX) announced today’s presentation of H1N1 vaccine results at the Immunotherapeutics & Vaccine Summit in Providence, RI. BioSante’s vaccine adjuvant, BioVant?, increased the protective effect of vaccines for multiple flu strains, including a potential new vaccine against H1N1 (swine flu), which resulted in 100 percent protection from symptoms of illness, including weight loss, and death in animal studies.
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