Canadian Pharmacy Blog

The FDA has approved two additional uses for rituximab (Rituxan, Genen-tech/Biogen Idec) for patients with CD20-positive, B-cell non-Hodgkin’s lym-phoma (NHL): as a first-line treatment of previously untreated patients with fol-licular NHL in combination with cyclo-phosphamide, vincristine, and predni-solone (CVP) chemotherapy, and as a treatment for low-grade NHL in patients with stable disease or who have achieved a partial or complete response following first-line treatment with CVP chemotherapy.

A therapeutic antibody, rituximab depletes CD20-positive B-cells without targeting stem cells or existing plasma cells.

In 1997, rituximab was approved to treat relapsed or refractory low-grade or follicular, CD20- positive, B-cell NHL. In 2006, it was approved for treating diffuse large B-cell lymphoma (DLBCL) in combination with cyclophosphamide, doxorubicin, vincristine, and generic prednisone (CHOP) or other anthracycline-based chemotherapy in previously untreated patients. That same year, it was also approved, in combination with metho-trexate, to reduce signs and symptoms in adults with moderately to severely active rheumatoid arthritis who responded inadequately to one or more tumor necrosis factor-antagonist therapies.

Rituximab is approved in the European Union under the trade name MabThera.

Coagulation factor VIIa (recombinant) (NovoSeven, Novo Nordisk) is the first recombinant therapy to be approved for the treatment of bleeding episodes and for the prevention of bleeding in patients with acquired hemophilia who are undergoing invasive surgical procedures.

First introduced in 1999, NovoSeven is currently indicated for the treatment of bleeding episodes in hemophilia A or B patients with inhibitors to factor VIII or factor IX and for bleeding episodes in patients with congenital factor VII deficiency. It is also indicated for prevention of bleeding in surgical interventions or invasive procedures in these patients.
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Functionally indistinguishable from naturally occurring activated factor VII, NovoSeven is produced in baby hamster kidney cells that have been genetically engineered to express recombinant factor VII. This agent is not derived from plasma, and it poses no risk of human viral transmission through its use.

Posaconazole oral suspension (Noxafil, Schering-Plough) is now approved for patients with oropharyngeal candi-diasis, including infections refractory to itraconazole and/or fluconazole.
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Sitagliptin generic phosphate (Januvia, Merck), the first diabetes treatment approved in a new class of drugs known as DDP-4 inhibitors, enhances the body’s own ability to lower elevated blood glucose levels.

The FDA approved the tablets for use in addition to diet and exercise to improve blood sugar levels in patients with type-2 diabetes; the drug can be used alone or in combination with two other oral diabetes medications: metformin generic (Glucophage, Bristol-Myers Squibb) or a peroxisome proliferator-activated receptor gamma (PPAR) agonist when either of these drugs alone do not provide adequate blood glucose control.

Januvia decreases the amount of sugar made by the body. It is unlikely to cause hypoglycemia because it does not work when blood glucose levels are low. It prolongs the activity of proteins that increase the release of insulin after blood glucose levels rise, such as after a meal. It blocks an enzyme (dipeptidyl peptidase IV or DPP-IV), which breaks down these proteins, leading to better blood sugar control.

Januvia drug was evaluated in 2,719 patients, but it has not been studied in children under 18 years of age or with medications that cause low blood sugar, such as sulfonylureas and insulin.

It should not be used for patients with type-1 diabetes mellitus or diabetic keto-acidosis.

The usual dose is 100 mg daily. Re-nally impaired patients may need a reduction in dose to either 50 mg or 25 mg.

The FDA has approved an expanded indication for the human monoclonal antibody adalimumab (Humira, Abbott) that includes inhibiting structural joint damage and improving physical function in patients with psoriatic arthritis (PsA). This indication is in addition to the approval for PsA that was granted in October 2005.

This product is also approved for moderate-to-severe rheumatoid arthritis and active ankylosing spondylitis.
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PsA, an autoimmune disorder, combines symptoms of arthritis, including joint pain and inflammation, and those of psoriatic skin disease, such as painful, raised red lesions covered by silvery-white scales. The additional indication was based on results from an extension of the Adalimumab Effectiveness in Psoriatic Arthritis Trial (ADEPT).

Pramipexole dihydrochloride tablets (Mirapex, Boehringer Ingelheim) has been approved for the treatment of moderate-to-severe primary restless legs syndrome (RLS). RLS is a common neurological sensorimotor disorder. Patients typically describe an urge to move the legs, and they may experience burning, creeping, crawling, aching, tingling, or tugging sensations in the legs. Up to 10% of adults in the U.S. are affected.
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Pramipexole is also approved to treat Parkinson’s disease.

Barr Pharmaceuticals, Inc. and its subsidiary Pliva d.d. have announced that Pliva has received final approval from the FDA for its ANDA to manufacture and market Pravastatin tablets in dosages of 10 mg, 20 mg, and 40 mg. The tablets are the generic version of Bristol-Myers Squibb’s Pravachol tablets. Pliva has also received tentative ap­proval to make the 80-mg dose.

Pravastatin is indicated for the primary prevention of coronary events in patients with elevated cholesterol levels who do not have clinically evident coronary heart disease and for the secondary prevention of cardiovascular events in patients with clinically evident coronary heart disease.