New Generics
- Donepezil orally disintegrating tablets (generic Aricept ODT)1
- Nizatadine oral solution (generic Axid oral solution), 15mg/mL.2 It is available in peppermint flavor.
New Drugs, Indications, and Dosage Forms
- Clonidine ER tablets and suspension (Clonidine ER suspension and Clonidine ER tablets) have been approved by the FDA.3
- Estradiol 10 mcg vaginal (Vagifem) low-dose tablets have been approved by the FDA for treating atrophic vaginitis due to menopause.4
- Olanzapine (Zyprexa) has been approved by the FDA to treat schizophrenia and manic or mixed episodes associated with bipolar I disorder in patients aged 13 to 17 years old.5 Prescribers must consider the potential for weight gain and hyperlipidemia, as well as other long-term risks that might occur in adolescents compared with adult patients.
- Olanzapine injection (Zyprexa Relprevv) has been approved by the FDA for treating schizophrenia in adults.6 A risk-evaluation and mitigation strategy (REMS) will be implemented with this agent. It is a long-acting, intramuscular depot injection given every two to four weeks, depending on the dose.7
- Quetiapine extended-release (Zyprexa) has been approved by the FDA as add-on therapy to antidepressants in managing adults with major depressive disorder.8 AstraZeneca, the drug manufacturer, also is seeking approval for a monotherapy indication to manage depression in the acute and maintenance phases.
- Sildenafil intravenous (Revatio IV) has been approved by the FDA for treating pulmonary arterial hypertension for patients who are temporarily unable to take the oral medication.9 The injection is administered as a single-dose of 10 mg up to three times daily. According to the manufacturer, this is bioequivalent to 20 mg three times a day for the oral formulation.
- Tiotropium bromide inhalation powder (Spiriva HandiHaler) has been approved by the FDA for reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD).10
Pipeline
- Approval is pending for Aztreonam lysine inhaled (Cayston) for the treatment of Pseudomonas aeruginosa infections in patients with cystic fibrosis.11 The FDA’s Anti-Infectives Drugs Advisory Committee voted 15-2 in favor of the drug’s safety and effectiveness, and 17-0 in favor of a regimen of 75 mg three times a day. The FDA usually approves drugs recommended by its panels.
- Darapladib, a selective and orally active LpPLA2 inhibitor, has begun Phase 3 clinical trials in the management of acute coronary syndrome (ACS).12 The study will include 11,500 male and female patients from 40 countries. It is a double-blind, randomized, placebo-controlled clinical efficacy trial of the long-term use of darapladib when added to standard of care. The study will test whether darapladib affects the chances of having a cardiovascular event, such as a myocardial infarction or a stroke, when treatment is started within 30 days after an ACS.
- Denosumab has received a positive opinion from the European Union for treating osteoporosis in postmenopausal women at increased risk of fractures, and also for treating bone loss in men with prostate cancer who are at increased risk of fractures.13 In the U.S., approval by the FDA is pending for management of osteoporosis in postmenopausal women.14 The FDA’s reproductive health advisory committee, which evaluated the agent, voted 12-1 to require the drug to carry a REMS.
- Ocrelizumab, a Phase 3 humanized anti-CD20 monoclonal antibody for treating rheumatoid arthritis (RA), recently reported positive results when given in combination with methotrexate (MTX) in an international, randomized, multicenter, double-blind trial.15 Ocrelizumab or placebo administered by intravenous infusion on days one and 15 met the primary endpoint of improving the signs and symptoms of RA in patients with an inadequate response to MTX.
- A response to an FDA complete response letter dated May 2009 was expected for rivaroxaban, an oral, direct Factor Xa inhibitor for preventing DVT and pulmonary embolism in patients undergoing hip or knee surgery. Complete review of rivaroxaban data was deferred by its manufacturers until February.16,17
- The FDA is considering a new indication for rosuvastatin (Crestor), following recommendations of the Endocrinologic and Metabolic Drugs Advisory Committee on Dec. 15, 2009.18
