Aug
31
New Drug Approvals in August
August 31, 2009 | Leave a Comment
Livalo: pitavastatin 1mg, 2mg, 4mg oral tablets
- A new statin drug used for treating hyperlipidemia (high cholesterol: total cholesterol, LDL cholesterol, and triglycerides) and increasing the good cholesterol (HDL).
- Get more information at our RxInfoBlog Drug Info Guide .
Renvela: sevelamer 0.8g, 2.5g oral powder
- This drug is used to control serum phosphorus in patients with Chronic Kidney Disease. It has been on the market as an oral tablet but the powder formulation is new.
- Get more information at our RxInfoBlog Drug Info Guide .
Saphris: asenapine 5mg, 10mg sublingual tablets
- An atypical antipsychotic drug used for treating schizophrenia and bipolar disorders in adults.
- Get more information at our RxInfoBlog Drug Info Guide .
Embeda: morphine and naltrexone, 20mg-0.8mg, 30mg-1.2mg, 50mg-2mg, 60mg-2.4mg, 80mg-3.2mg, 100mg-4mg extended release capsules for oral use
- This drug is used for treating moderate to severe pain (not for prn use).
- Get more information at our RxInfoBlog Drug Info Guide .
Fibricor: fenofibric acid 35mg, 105mg oral tablets
- This drug is used to treat high cholesterol.
Extavia: Interferon Beta - I B 0.625mg subcuntaneous injections
- A drug used to treat relapsing forms of multiple sclerosis.
- Get more information at our RxInfoBlog Drug Info Guide .
Sabril: vigabatrin 500mg oral tablets
- A new epilepsy drug for treating seizures (refractory complex partial seizures) in adults.
- Get more information at our RxInfoBlog Drug Info Guide .
Zenpep: pancrelipase 500 units oral delayed release capsule
- A combination of porcine-derived lipases, proteases, and amylases used in the treatment of exocrine pancreatic insufficiency.
- Get more information at our RxInfoBlog Drug Info Guide .
Valcyte: vanganciclovir 50mg/ml oral solution
- Used in the treatment of cytomegalovirus retinitis in AIDS and in the prevention of CMV disease in kidney, heart, and kidney-pancreas transplant patients. This drug has been on the market in tablet form but the oral solution is a new formulation.
- Get more information at our RxInfoBlog Drug Info Guide .
Mar
31
New First-Time Generic Drug Approvals for February
March 31, 2009 | Leave a Comment
|
Brand Name |
New Generic Name |
Generic Manufacturer |
Approval Date |
| Solodyn Tablets | Minocycline ER tablets 45mg, 90mg, 135mg | Impax |
2/3/2009 |
| Imitrex Injections | Sumatriptan 4mg, 6mg vials and prefilled syringes | Sandoz, Bedford, Teva |
2/6/2009 |
| Imitrex Tablets | Sumatriptan 25mg, 50mg, 100mg | Teva, Ranbaxy |
2/9/2009 |
| Risperdal M-Tab | Risperidone orally disintegrating tablets 0.5mg, 2mg | Dr Reddy’s |
2/24/2009 |
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Mar
13
New Drug: Edluar
March 13, 2009 | Leave a Comment
Active ingredient(s): zolpidem tartrate 5mg, 10mg
Dosage form: buccal/sublingual tablets
Manufacturer: Orexo
Usage: short-term treatment of insomnia characterized by difficulties with sleep initiation.
Approval Date: March 13, 2009
For more information visit http://www.fda.gov/cder/foi/label/2009/021997lbl.pdf
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Feb
26
New First-Time Generic Drug Approvals for January
February 26, 2009 | Leave a Comment
|
Brand Name |
New Generic Name |
Generic Manufacturer |
Approval Date |
| Niravam | Alprazolam orally disintegrating tablets 0.25mg, 0.5mg, 1mg, 2mg | Kali Lab |
01/09/2009 |
| Keppra Oral Solution | Levetiracetam oral solution, 100mg/ml | Actavis, Aurobindo, Tolmar, Roxane |
01/15/2009 |
| Depakote Sprinkle Capsules | Divalproex sodium delayed release tablets, 250mg, 500mg | Dr Reddy |
01/23/2009 |
| Depakote ER Tablets | Divalproex sodium ER tablets, 250mg, 500mg | Mylan |
1/29/2009 |
| Risperdal Oral Solution | Risperidone oral solution | Teva |
1/30/2009 |
| Razadyne Oral Solution | Galantamine Hydrobromide oral solution, 4mg/ml | Roxane |
1/30/2009 |
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Feb
13
New Drug: Uloric
February 13, 2009 | Leave a Comment
Active ingredient(s): Febuxostat
Dosage form: 40mg and 80mg oral tablets
Manufacturer: Takeda
Usage: a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia in patients with gout.
Approval Date: February 13, 2009
For more information visit http://www.uloric.com/?gclid=CJaImZvi85gCFQRkswodZH290w
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Jan
30
New Drug: Kapidex
January 30, 2009 | Leave a Comment
Active ingredient(s): Dexlansoprazole
Dosage form: oral delayed release capsules, 30mg, 60mg, 90mg
Manufacturer: Takeda
Usage: a proton pump inhibitor used for healing of all grades of erosive esophagitis (EE), maintaining healing of EE, and treating heartburn associated with non-erosive gastroesophageal reflux disease (GERD).
Approval Date: January 30, 2009
For more information visit https://www.kapidex.com/default.aspx
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Jan
30
New Drug: Isentress
January 30, 2009 | Leave a Comment
Active ingredient(s): Raltegravir potassium
Dosage form: 400mg oral tablets
Manufacturer: Merck
Usage: a human immunodeficiency virus integrase strand transfer inhibitor used in the treatment of HIV adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.
Approval Date: January 30, 2009
For more information visit http://www.isentress.com/raltegravir/isentress/index.jsp
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Jan
28
New Drug: Gelnique
January 28, 2009 | Leave a Comment
Active ingredient(s): Oxybutynin chloride
Dosage form: 10% topical gel
Manufacturer: Watson
Usage: treatment of overactive bladder
Approval Date: January 28, 2009
For more information visit http://www.gelnique.com/index.asp
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Jan
23
New Drug: Vectical
January 23, 2009 | Leave a Comment
Active ingredient(s): Calcitriol
Dosage form: 3 ugm/gm topical ointment
Manufacturer: GaldermaUsage: a vitamin D analog indicated for the topical treatment of mild to moderate plaque psoriasis in adults 18 years and older.
Approval Date: January 23, 2009
For more information visit http://www.fda.gov/cder/foi/label/2009/022087lbl.pdf
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
Jan
14
New Drug: Savella
January 14, 2009 | 2 Comments
Active ingredient(s): Milnacipran HCl
Dosage form: Oral tablets, 12.5mg, 25mg, 50mg, 100mg
Manufacturer: Forest Labs
Usage: A selective serotonin and norepineprhine reuptake inhibitor indicated for the management of fibromyalgia.
Approval Date: January 14, 2009
For more information visit http://www.savella.com/
Disclaimer: All contents published on RxInfoBlog.com is provided for informational and educational purposes only. Like any printed material, it may become out-of-date over time. The site and its services are not a substitute for professional medical advice and treatment. Always seek the advice of your doctor before making any changes to your diet, health routine, or treatment.
