Trusted Pharmacy Blog|New Drugs, Drug News, Health, Medications, Diseases

Centocor has announced the FDA’s approval of infliximab (Remicade) for maintaining clinical remission and muco-sal healing in patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy.

The approval was based primarily on one-year data from the ACT 1 randomized, double-blind, multicenter, placebo-controlled clinical trial. Patients receiving infliximab were nearly three times as likely as patients in the placebo group to maintain clinical remission from their symptoms after one year. In addition, 45% of the infliximab patients, but only 18% of the placebo patients, experienced muco-sal healing at week 54.
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Infliximab was first approved in the U.S. for the treatment of Crohn’s disease (CD) in 1998. It was later approved for patients with ulcerative colitis in 2005. With this expanded indication for maintenance therapy in ulcerative colitis, infliximab is the only biological agent indicated for inducing and maintaining clinical remission of both types of inflammatory bowel disease.

The FDA has approved telbivudine (Tyzeka, Novartis Pharma Stein AG, Stein) for the treatment of adults with chronic hepatitis B, a viral infection of the liver. HBV can cause lifelong infection; cirrhosis; and eventually liver cancer, liver failure, and death.
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Telbivudine contains an active substance that has not been previously approved for marketing in any form in the U.S. The drug was studied in a yearlong international clinical trial of 1,367 patients with chronic HBV.

Vorinostat capsules (Zolinza, Pantheon/Merck) capsules have been approved for the treatment of cutaneous T-cell lymphoma.

The product was approved as part of the FDA’s orphan drug program. Every year in the U.S., this form of lymphoma strikes about three in every one million people, mostly men with an average age of 50 years.

Evidence of the product’s safety and effectiveness was developed in two trials. A response, defined by improved scores on a scale that evaluates skin lesions, occurred in 30% of patients who received the drug, and the response lasted for an average of 168 days.
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Serious ADEs included pulmonary embolism, dehydration, deep vein thrombosis, and anemia.

Vorinostat has not been studied in pregnant women, but animal studies suggest that it may cause fetal harm when administered during pregnancy.

Sepracor, Inc., has announced the Food and Drug Administration’s (FDA’s) approval of its New Drug Application (NDA) for arformoterol tartrate generic (Brovana) Inhalation Solution 15 mcg as a long-term, twice-daily maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.

Brovana is the first long-acting beta₂-agonist to be approved as an inhalation solution for use with a nebulizer.

Sepracor completed more than 100 preclinical and 16 clinical studies involving more than 2,000 patients.

Nitroglycerin Lingual Aerosol (Nitro-Mist, Nova Del Pharma) has been approved for the acute relief of an attack or acute prophylaxis of chest pain caused by coronary artery disease.

NitroMist is Nova Del’s first approved product to use a proprietary oral spray technology. The North American com mercial rights have been licensed to Par Pharmaceutical. buy antibiotics in canada

Severe hypotension, particularly with upright posture, may occur with even small doses of nitroglycerin. This drug should therefore be used with caution in patients who may be volume-depleted or who are already hypertensive.

The FDA has approved a combination of drug clindamycin phosphate 1.2% and tretinoin 0.025% (Ziana, Medicis/Dow Pharmaceutical Sciences, Inc.) for the topical treatment of acne vulgaris in patients 12 years of age or older. The gel is the first approved acne product to combine an antibiotic and a retinoid.

Available by prescription in 30-g and 60-g tubes, the product has an alcohol-free, aqueous base.

Adverse events include nasopharyngitis, pharyngolaryngeal pain, dry skin, cough, and sinusitis. The gel is con-traindicated in people with regional enteritis, ulcerative colitis, or a history of antibiotic-associated colitis. Exposure to sunlight, including sunlamps, should be avoided during use.

Final approval has been granted for Mylan’s Abbreviated New Drug Applications (ANDAs) for drug oxybutynin chloride extended-release 5-mg and 10-mg tablets. The product is the generic version of Alza Corporation’s Ditropan XL.

As a genitourinary antispasmodic agent, the tablets are indicated for over-active bladder.