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Prescription Drugs

Orphan Australia Receives Approval For New Dose Form DepoDur

Orphan Australia Pty Ltd, dedicated to providing novel, highly specialized pharmaceuticals, has been granted registration approval by the Therapeutic Goods Administration for DepoDur in Australia. DepoDur, which was developed by and licensed from Pacira Pharmaceutical, Inc. and utilizes Pacira's DepoFoam technology, is a novel, single dose modified-release formulation of morphine.

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Sequella Lead Drug Compound Receives Orphan Drug Status From FDA

FDA and the European Medicines Agency (EMEA) independently reviewed Sequella lead drug compound, SQ109, and both agencies granted SQ109 orphan drug status for the treatment of tuberculosis. SQ109 shows excellent in vitro and in vivo activity against drug-susceptible and drug-resistant TB bacteria, including XDR-TB.

Further, SQ109 synergizes with other TB drugs in experimental animal models of TB, and could result in new TB drug combinations that have much greater activity than the current standard of care.

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FDA Cleares Allient Sorbent Hemodialysis System For Chronic, Acute Hemodialysis

Renal Solutions has received 510(k) clearance from FDA for its newly enhanced Allient Sorbent Hemodialysis System in chronic and acute hemodialysis applications. The new Allient System features improvements in ease of manufacturing, service and user-friendliness. In preparation for the Allient System commercialization, Renal Solutions is also launching its SMARRT (Sorbent Management for Advanced Renal Replacement Therapy) platform and campaign, which will introduce the benefits of advanced sorbent therapy to the renal community.

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Optimizing Your Internal Process For FDA Compliance

With safety issues making headlines, pharmaceutical and medical device manufacturers face a rugged regulatory landscape. Organizations are relying on their quality function to navigate regulatory difficulties that could affect production. Proper staffing of quality roles is just one way organizations optimize their quality function and a study by pharmaceutical benchmarking leader Best Practices, LLC found best-in-class companies have a ratio of quality personnel to total manufacturing employees between 1:4 and 1:7.

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FDA Approves Drug To Treat Complicated Urinary Tract, Intra-Abdominal Infections

FDA has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.

"This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections," said Janet Woodcock, M.D., FDA's deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

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Legislation To Allow Small Pharmacies To Collaborate On Negotiations With Health Insurers

Independent pharmacists urged lawmakers to pass legislation that would exempt small pharmacies from antitrust laws and allow them to collaboratively negotiate reimbursements with health insurers and pharmacy benefit managers.

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Medi-Scripts Prescription Pad Product Adds Patient Offers

Medi-Promotions launched next generation prescription pad model -- Medi-Scripts PLUS. Building on the 27-year success of its Medi-Scripts prescription pad service model, Medi-Scripts PLUS will include patient offers on behalf of its advertisers whom leverage the list of more than 200,000 Medi-Scripts prescribers requesting and using its prescription pads free of charge in their practices on a daily basis.

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Genencor Launches Commercial Enzyme Product For Cellulosic Ethanol

Genencor announced a new product, Accellerase 1000, the first ever commercially available biomass enzyme developed specifically for second generation biorefineries. Accellerase 1000 contains a potent complex of enzymes that reduces complex lignocellulosic biomass into fermentable sugars -- an indispensable step for the production of cellulosic ethanol.

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