Generic Drug Approvals

See also: New Drug Approvals, New Drug Applications, Recent Additions to Drugs.com

Latest Generic Drug Approvals


First-Time Generic Approvals November 2008

  • Rocuronium Bromide Injection 10 mg/mL packaged in 5 mL and 10 mL Multiple-Dose Vials
    Approved: November 26, 2008 Hospira Inc.; Teva Parenteral Medicines, Inc.; Generamedix, Inc.
    Generic for: Zemuron Injection
  • Methylergonovine Maleate Injection USP 0.2 mg/mL
    Approved: November 24, 2008 Pharmaforce, Inc.
    Generic for: Methergine
  • Budesonide Inhalation Suspension 0.25 mg/2 mL and 0.5 mg/2 mL; packaged in Unit-Dose Vials
    Approved: November 18, 2008 IVAX Pharmaceuticals
    Generic for: Pulmicort Respules Inhalation Suspension
  • Calcitonin-Salmon Nasal Spray 200 IU/Spray
    Approved: November 17, 2008 Apotex, Inc.
    Generic for: Miacalcin Nasal Spray
  • Levetiracetam Tablets 250 mg, 500 mg and 750 mg
    Approved: November 3, 2008 Mylan Pharmaceuticals, Inc.
    Generic for: Keppra Tablets

Generic Drug Approvals Archive


2008: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov
2007: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2006: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2005: Jan | Feb | Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec
2004: Mar | Apr | May | Jun | Jul | Aug | Sep | Oct | Nov | Dec

More News Resources


MedNotes
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December 22, 2008
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December 11, 2008
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Latest Drug Information Updates

Nexterone
Nexterone (amiodarone HCl) Injection is a cosolvent free formulation of the antiarrhythmic agent Amiodarone IV, originally marketed in the US by Wyeth as Cordarone Intravenous. Nexterone is indicated for the treatment and prophylaxis of frequently recurring ventricular fibrillation and hemodynamically unstable ventricular tachycardia in patients refractory to other therapy.

Latisse
Latisse (bimatoprost ophthalmic) is a prostamide indicated for the treatment of hypotrichosis (or reduced amount of hair) of the eyelashes. Growth of the eyelashes is a well documented side effect of bimatoprost which is currently approved as Lumigan for the treatment of glaucoma.

BioThrax
BioThrax (Anthrax Vaccine Adsorbed) is a vaccine indicated for the active immunization for the prevention of disease caused by Bacillus anthracis, in persons between 18 and 65 years of age at high risk of exposure.

Mozobil
Mozobil (plerixafor) is a small molecule CXCR4 chemokine receptor antagonist used in combination with granulocyte-colony stimulating factor to mobilize hematopoietic stem cells to the bloodstream for collection and subsequent autologous transplantation in patients with non-Hodgkin’s lymphoma and multiple myeloma.

Trilipix
Trilipix (fenofibric acid) is a peroxisome proliferator receptor alpha (PPARα) activator indicated for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. Trilipix is the first and only fibrate to be approved for use in combination with a statin.

Synthetic Conjugated Estrogens-A (SCE-A) Vaginal Cream
SCE-A (synthetic conjugated estrogens, A) Vaginal Cream is a plant-derived local estrogen product indicated for the treatment of moderate to severe vaginal dryness and pain with intercourse, both of which are symptoms of vulvar and vaginal atrophy due to menopause.

Lusedra
Lusedra (fospropofol disodium) is an intravenous sedative-hypnotic agent for monitored anesthesia care (MAC) sedation in adult patients undergoing diagnostic or therapeutic procedures.

Promacta
Promacta (eltrombopag) is a thrombopoietin receptor agonist indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura.

Banzel
Banzel (rufinamide) is a triazole derivative antiepileptic drug for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome.

Apriso
Apriso (mesalamine) is a once-daily, locally-acting aminosalicylate indicated for the maintenance of remission of ulcerative colitis (UC) in adults.

LoSeasonique
LoSeasonique is a lower-dose, extended-cycle oral contraceptive indicated for the prevention of pregnancy.

Acanya
Acanya (benzoyl peroxide and clindamycin phosphate) is a topical antibacterial and antibiotic combination for the treatment of acne.

Toviaz
Toviaz (fesoterodine fumarate) is a competitive muscarinic receptor antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

Vimpat
Vimpat (lacosamide) is an anti-convulsant drug for the treatment of partial onset seizures in adults with epilepsy.

Astepro
Astepro (azelastine) is a nasal antihistamine for the treatment of seasonal allergic rhinitis.

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