NEW DRUG APPROVALS BY FDA
DA Approves Stendra for Erectile Dysfunction
4/30/2012
The FDA has approved Vivus’s Stendra (avanafil), a phosphodiesterase type 5 (PDE5) inhibitor, indicated for the treatment of erectile dysfunction.Stendra will be available in 50, 100, and 200 mg tablets, with a recommended starting dose for most patients of 100 mg taken 30 minutes prior to sexual activity. Stendra should not be taken more than once daily and should not be coadministered with nitrates because a sudden drop in blood pressure may occur.
FDA Approves Dymista
The FDA has approved Meda's Dymista nasal spray for the treatment of seasonal allergic rhinitis in patients 12 years and older who require treatment with both azelastine hydrochloride and fluticasone propionate for symptomatic relief.
FDA Approves Elelyso
The FDA has approved Pfizer's Elelyso (taliglucerase alfa) for injection, an enzyme replacement therapy for the long-term treatment of adults with type 1 Gaucher disease.
Fabior Foam
The FDA has approved Stiefel's Fabior (tazarotene) 0.1% foam for the treatment of acne vulgaris in patients 12 years of age and older.
Pertzye
The FDA has approved Digestive Care's Pertzye (pancrelipase) delayed-release capsules for treatment of exocrine pancreatic insufficiency caused by cystic fibrosis or other conditions. The Pertzye formulation was previously marketed under the trade name Pancrecarb MS-16 .
Generic Requip XL Approved
Actavis has received FDA approval of the first generic equivalent to GlaxoSmithKline's Requip XL (ropinirole) extended-release tablets 2, 4, 6, 8, and 12 mg. Ropinirole extended release is indicated for the treatment of the signs and symptoms of idiopathic Parkinson disease.
Generic Plavix
The FDA has approved generic versions of drug Plavix (clopidogrel bisulfate), indicated for the treatment of acute coronary syndrome, recent myocardial infarction, recent stroke, or established peripheral arterial disease. Clopidogrel must be dispensed with a patient Medication Guide ... Read more
Generic Viramune Available
Roxane Laboratories has announced the immediate availability of generic Viramune (nevirapine) tablets and oral suspension. Nevirapine is indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.
Butoconazole Nitrate 2% Vaginal Cream
The FDA has approved Perrigo's butoconazole nitrate 2% vaginal cream, the generic equivalent of KV Pharmaceutical's Gynazole-1, indicated for the local treatment of vulvovaginal candidiasis. The product is expected to launch by the end of 2012.
Generic Delsym
The FDA has granted approval to Perrigo Company and Tris Pharma for an abbreviated new drug application for the generic equivalent to Reckitt Benckiser's Delsym (dextromethorphan polistirex) extended-release oral suspension. Dextromethorphan is indicated for the temporary ... Read more
Absorica
The FDA has approved Cipher Pharmaceuticals' Absorica (isotretinoin) for the treatment of severe recalcitrant nodular acne. Absorica is expected to be launched in the US in late 2012.
Perjeta for Treatment of Breast Cancer
The FDA has approved Roche's Perjeta (pertuzumab), a humanized monoclonal antibody, for the treatment of human epidermal growth factor receptor 2 (HER2)–positive late-stage (metastatic) breast cancer. Perjeta is intended for patients who have not received prior treatment for ... Read more
MenHibrix Vaccine
The FDA has approved GlaxoSmithKline's MenHibrix (meningococcal groups C and Y and Haemophilus b tetanus toxoid conjugate vaccine), indicated to prevent invasive disease caused by Neisseria meningitidisserogroups C and Y and Haemophilus influenzae type b. MenHibrix is approved for use in children aged 6 weeks through 18 months.
Belviq for Weight Loss
The FDA has approved Arena Pharmaceuticals' and Eisai's Belviq (lorcaserin hydrochloride), indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adult patients with an initial body mass index (BMI) of 30 kg/m2 or greater ... Read more
Generic Detrol Tablets Approved
The FDA has approved Teva Pharmaceuticals' generic equivalent to Pfizer's Detrol (tolterodine tartrate) tablets 1 and 2 mg. Tolterodine tartrate is indicated for treatment of overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence.
FDA Approves Generic Duac Gel
The FDA has approved Perrigo's clindamycin phosphate 1.2%/benzoyl peroxide 5% topical gel, the generic equivalent of Stiefel Laboratories' Duac gel. Duac gel is indicated for the topical treatment of inflammatory acne vulgaris. Perrigo has commenced shipment of the product.
NEW INDICATIONS
Afinitor
The FDA has approved Afinitor (everolimus) for the treatment of noncancerous kidney tumors (renal angiomyolipomas) not requiring immediate surgery in patients with tuberous sclerosis complex (TSC). Afinitor is also indicated for the treatment of progressive neuroendocrine tumors ... Read more
Votrient
The FDA has approved GlaxoSmithKline's Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Votrient was previously granted orphan drug status for this new indication. Pazopanib is also indicated for the treatment of ... Read more
Levaquin Approved to Treat Plague
The FDA has approved Janssen Pharmaceuticals' Levaquin (levofloxacin) to treat patients with plague, a rare and potentially deadly bacterial infection, as well as for use in reducing the risk of contracting plague after exposure toYersinia pestis, the bacterium that causes the disease ... Read more
Expanded Levemir Pediatric Indication
The FDA has approved expanded labeling for Novo Nordisk's Levemir (insulin detemir [rDNA origin] injection) to include children 2 to 5 years of age with type 1 diabetes. Insulin determir is now approved for glycemic control in patients from age 2 years through adulthood with type 1 diabetes and in adults with type 2 diabetes.
Durezol
The FDA has approved Alcon Vision's Durezol (difluprednate ophthalmic emulsion) 0.05% for the treatment of endogenous anterior uveitis. Durezol is also indicated for the treatment of inflammation and pain associated with ocular surgery.
Atripla Approved for Pediatric Use
The FDA has approved Atripla (efavirenz/emtricitabine/
Lyrica
The FDA has approved Pfizer's Lyrica (pregabalin) capsules for the management of neuropathic pain associated with spinal cord injury. Lyrica received priority review for this new indication. Lyrica was previously indicated for the management of fibromyalgia; for the management of ... Read more
DRUG RECALLS
Imodium Multi-Symptom Relief Recall
McNeil has informed its wholesale customers in the US that it is voluntarily recalling 1 lot (CMF023, found on the side of the product box) of the 18-caplet package size of Imodium Multi-Symptom Relief(loperamide/simethicone) due to a packaging issue. The product is being recalled at the wholesale level only, not from consumers or store shelves ... Read more
Advil Liqui-Gels Recalled
Pfizer has recalled several lots of Advil Liqui-Gels 200 mg (ibuprofen), 40 count, 40+20 count, and 240 count bottles due to a stronger odor caused by increased enzymatic hydrolysis time for the gelatin manufacturing process ... Read more
Franck's Compounded Preparations Recall
The FDA is notifying all health care providers and medical care organizations who have ordered sterile compounded products from Franck's Compounding Pharmacy of Ocala, FL, of a recall due to a possible lack of sterility. ... Read more
Introvale Oral Contraceptive Recalled
Sandoz announced a voluntary recall of 10 lots of its generic oral contraceptive Introvale (levonorgestrel/ethinyl estradiol tablets), distributed in the United States between January 2011 and May 2012. The recall was issued after a reported packaging flaw in which the white placebo tablets were mistakenly in the ninth row of ... Read more
FDA Recalls Wellesse Digestive 3-in-1 Supplement
The FDA has issued a recall of select lots of Botanical Laboratories' Wellesse Digestive 3-in-1 Health liquid dietary supplement. Affected lots were distributed in the US after May 1, 2012, and include the 16 oz size with "LOT 34441C (followed by a 4-digit time code) A EXP 03/2014" jet ... Read more
Merck Issues Voluntary Recall of M-M-R II
Merck announced a voluntary recall of one lot (0851AA) of M-M-R II (measles, mumps, and rubella virus vaccine, live) because of an inadvertent shipment of doses to US customers between May 17, 2012 and May 25, 2012, prior to final internal approval for market release ... Read more
OTHER DRUG NEWS
Victrelis Interactions Warning
The FDA is notifying the public that Victrelis (boceprevir), a hepatitis C virus (HCV) protease inhibitor, should not be coadministered with certain ritonavir-boosted HIV protease inhibitors because of the possibility of reduced effectiveness of HCV or HIV treatment. Ritonavir-boosted ... Read more
Zortress Black Box Warning Revised
The FDA has approved a revised black box warning for Zortress (everolimus) noting that increased mortality was observed in a heart transplant clinical trial and that use in heart transplantation is not recommended. Zortress is indicated for the prophylaxis of organ rejection in adult patients at low to moderate immunologic risk receiving a kidney transplant.
Lexiva Pediatric Dosing Expanded
The FDA has approved expanded dosing recommendations for use of GlaxoSmithKline's Lexiva (fosamprenavir) oral suspension in pediatric patients; the label now includes dosing for pediatric patients 4 weeks to 18 years of age. The dosage should be calculated based on body weight and ... Read more
FDA Advises Caution With Bisphosphonates
In response to serious postmarketing adverse reactions, including atypical femur fractures, osteonecrosis of the jaw, and esophageal cancer, the FDA conducted a systematic review of long-term bisphosphonate efficacy. This class includes alendronate (Fosamax), etidronate ... Read more
CCSVI Therapy Alert
The FDA is alerting health care providers and patients about injuries and death associated with "liberation therapy" or the "liberation procedure" to treat chronic cerebrospinal venous insufficiency (CCSVI). CCSVI may cause multiple sclerosis (MS) or may contribute to the ... Read more
FDA Reviewing Study of Azithromycin and Cardiovascular Risk
The FDA is reviewing the results of a study published in the May 17, 2012, issue of the New England Journal of Medicine that compared the risk of cardiovascular death among patients treated with azithromycin (Zithromax), amoxicillin, ciprofloxacin (Cipro), levofloxacin (Levaquin), or no antibacterial drug ... Read more
Adderall Counterfeit Product
The FDA is warning consumers and health care providers about a counterfeit version of Teva Pharmaceutical Industries' Adderall 30 mg tablets, which contain the wrong active ingredient. Adderall's 4 active ingredients are dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. The counterfeit product contains tramadol ... Read more
Hospira Carpuject Prefilled Cartridges Alert
The FDA is alerting health care providers of a potential safety risk with as many as 280 lots of 15 differentCarpuject prefilled cartridges that may be overfilled by at least twice the expected amount, which may result in overdose. The company has identified the cause as a manufacturing ... Read more
FDA Issues Safety Alert for Reumofan Plus
The FDA is warning consumers that Riger Naturals' Reumofan Plus, marketed as a "natural" dietary supplement for pain relief and other serious conditions, contains several active ingredients not listed on the label that could be harmful. An FDA laboratory analysis found that Reumofan ... Read more
Prinzide Black Box Warning Revised
The FDA has approved a revised black box warning for Prinzide (lisinopril/
FDA Warns of Seizure Risk with Cefepime
The FDA is reminding health care providers about the need to adjust the dosage of cefepime in patients with renal impairment. Cases of nonconvulsive status epilepticus have been associated with the use of cefepime, primarily in patients with renal impairment who did not receive appropriate dosage adjustments ... Read more
Nguồn Facts and Comparisons
Nguồn Facts and Comparisons
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