Formulary Watch |

FDA actions in brief, June 2007

Briefs of FDA actions/approvals of drugs, doses, and indications

First-time generic approvals, June 2007

First-time generic drug approvals: Zolpidem immediate-release; nimodipine

FDA pipeline preview, June 2007

The latest FDA action (through June 2007) related to sipuleucel-T (Provenge), tramadol (CIP-Tramadol ER), isotretinoin (CIP-Isotretinoin), bazedoxifene (Viviant), irbesartan plus hydrochlorothiazide (Avalide), prednisolone 1.0% plus tobramycin 0.3% ophthalmic suspension (T-Pred), pixantrone, SPRC-AB01

Altabax: Retapamulin ointment, 1% recently approved by FDA as new molecular entity

Retapamulin ointment, 1% is now approved by FDA as an antibacterial agent for the topical treatment of impetigo due to Staphylococcus aureus or Streptococcus pyogenes.

Singulair: FDA approves new indication for montelukast

Montelukast, a leukotriene receptor antagonist, is now approved by FDA for the prevention of exercise-induced bronchoconstriction.

Drug Watch: Agents in late-stage development for the treatment of epiepsy/seizures (June 2007) (PDF)

A review of agents in late-stage development for the treatment of epilepsy/seizures (June 2007).

FDA actions in brief

Briefs of FDA actions/approvals of drugs, doses, and indications

Automated IV and syringe preparation increases safety, reduces errors

A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.

Gabapentin monotherapy as effective as gabapentin plus antidepressant in treatment of hot flashes

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.

Drug Watch: Agents in late-stage development for the treatment of HIV/AIDS (May 2007) (PDF)

A review of agents in late-stage development for the treatment of HIV/AIDS (May 2007).

Sitaxsentan: A new endothelin-receptor antagonist for the treatment of pulmonary arterial hypertension

FDA actions in brief

Briefs of FDA actions/approvals of drugs, doses, and indications

Policymakers weigh incentives for pediatric studies and policies to allow generic versions of biotech therapies

Pediatric exclusivity program and generic biotech therapies as related to PDUFA IV.

Targeted patient education increases formulary compliance in a 3-tier pharmacy benefit

Results of a study conducted to determine whether users of nonformulary blood glucose meters would increase their formulary compliance if they were provided with targeted information and an offer for a free formulary meter.

Automated IV and syringe preparation increases safety, reduces errors

A summary of several automated IV and syringe preparation systems and a discussion of the technology's impact on pharmacy efficiency.

SWISS II: Antiangina agents result in improved outcomes in patients with silent ischemia but without CAD

Patients with silent ischemia but no coronary artery disease (CAD) may benefit from treatment with antianginal drug therapy, according to results of The Swiss Interventional Study on Silent Ischemia Type I (SWISS II)

Nicotine patch demonstrated to be safe in smokers with CAD

Nicotine patches used for smoking cessation are safe in patients with coronary artery disease (CAD) and active stress-induced myocardial ischemia, according to the results of a randomized trial.

ARMYDA-ACS: Short-term atorvastatin treatment improves intervention outcomes

An 80-mg dose of atorvastatin administered 12 hours before angioplasty, followed by a 40-mg dose administered 2 hours before the procedure significantly reduces the risk of major cardiovascular events during the month after the intervention, according to the results of The Atorvastatin for Reduction of Myocardial Damage during Angioplasty-Acute Coronary Syndromes (ARMYDA-ACS) trial.

FUSION II: Nesiritide infusions in stage D HF not linked to increased risk of hospitalization, renal toxicity

Results of FUSION II, a randomized, double-blind, placebo-controlled study involving 920 patients with stage D chronic decompensated HF, presented at the 56th Annual Scientific Session of the ACC.

Biologic psoriasis treatment options expanding

New research presented at the AAD's 65th Annual Meeting regarding treatment of biologic psoriasis with adalimumab and efalizumab.

Researchers say anticoagulant prophylaxis in at-risk hospital patients can prevent VTE

A meta-analysis of randomized controlled trials demonstrated that anticoagulant prophylaxis of hospitalized patients statistically significantly reduced their risk of developing both a pulmonary embolism (PE) and deep vein thrombosis (DVT).

Intensive statin therapy demonstrated to be safe and effective in the elderly

Intensive statin therapy in elderly patients may be more effective than moderate statin therapy in improving lipid levels and reducing all-cause death, according to a prospective, international, multicenter, randomized, double-blind, double-dummy, parallel-arm trial in elderly patients with documented coronary artery disease (CAD).

Etoricoxib results in fewer upper GI events compared with diclofenac users according to MEDAL program

Patients with osteoarthritis or rheumatoid arthritis who are taking etoricoxib may experience significantly fewer upper gastrointestinal (GI) events compared with those taking diclofenac, according to the pooled results of 3 randomized trials.

Sorafenib improves progression-free survival in clear-cell renal-cell carcinoma

Sorafenib significantly improves progression-free survival in patients with advanced clear-cell renal-cell carcinoma, according to results from a phase 3, randomized, double-blind, placebo-controlled trial.

Beta-carotene, vitamin A, and vitamin E associated with increased risk of death

In a systematic review and meta-analysis, the use of beta-carotene, vitamin A, and vitamin E, either alone or combined, was associated with an increased risk of all-cause mortality.

Rosuvastatin effective at slowing progression of asymptomatic aortic stenosis

Prospective treatment with rosuvastatin can slow the hemodynamic progression of asymptomatic aortic stenosis. This was the conclusion of the prospective, open-label Rosuvastatin Affecting Aortic Valve Endothelium (RAAVE) trial.

Triple therapy for COPD demonstrates benefit, fails to meet end point in randomized study

In a randomized, double-blind, parallel-group trial, triple therapy with tiotropium plus salmeterol (SAL) and fluticasone failed to reduce the proportion of patients with chronic obstructive pulmonary disease (COPD) experiencing exacerbations requiring treatment with systemic corticosteroids and/or antibiotics (the primary end point) compared with tiotropium plus salmeterol or tiotropium alone.

Study suggests ASA plus OAC is effective in mechanical heart valve patients, but increases risk of bleeding

The combination of aspirin (ASA) and oral anticoagulation (OAC) significantly reduces the odds of thromboembolism, but has no effect on all-cause mortality versus OAC alone, according to a systematic review and meta-analysis.

Pooled analysis demonstrates regression of coronary atherosclerosis with statins

A post-hoc analysis invloving 4 prospective, randomized trials demonstrated that treatment of CAD with statins increases HDL-C, and the increases correlate with a positive impact on disease progression.

Gabapentin monotherapy as effective as gabapentin plus antidepressant in treatment of hot flashes

A phase 3 study evaluating the use of gabapentin alone and in combination with an antidepressant in women with hot flashes who had an inadequate response with antidepressant monotherapy demonstrated that gabapentin reduced hot flashes by approximately 50%, whereas the combination of an anti-depressant with gabapentin appeared to offer no additional benefit.