Generic Drug Approvals

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

Latest Generic Drug Approvals


First-Time Generic Approvals July 2008

  • Indomethacin for Injection USP 1 mg/vial
    Approved: July 16, 2008 Bedford Laboratories
    Generic for: Indocin IV, 1 mg/Vial
  • Doxycycline for Oral Suspension USP, 25 mg/5 mL
    Approved: July 16, 2008 IVAX Pharmaceuticals, Inc.
    Generic for: Vibramycin for Oral Suspension, 25 mg/5 mL
  • Nisoldipine Extended Release Tablets 20 mg, 30 mg and 40 mg
    Approved: July 25, 2008 Mylan Pharmaceuticals, Inc.
    Generic for: Sular Extended-Release Tablets
  • Mycophenolate Mofetil Capsules 250 mg
    Approved: July 29, 2008 Roxane Laboratories, Inc.
    Generic for: Cellcept Capsules, 250 mg
  • Divalproex Sodium Delayed-Release Tablets USP, 125 mg, 250 mg and 500 mg (Valproic Acid Activity)
    Approved: July 29, 2008 Dr. Reddy's Laboratories Limited; Sun Pharmaceutical Industries, Ltd.; Genpharm ULC; Upsher-Smith Laboratories, Inc.; Sandoz Inc.; Teva Pharmaceuticals USA; Lupin Limited
    Generic for: Depakote Delayed-Release Tablets
  • Mycophenolate Mofetil Tablets 500 mg
    Approved: July 29, 2008 Roxane Laboratories, Inc.
    Generic for: Cellcept Tablets, 500 mg
  • Eplerenone Tablets 25 mg and 50 mg
    Approved: July 30, 2008 Apotex, Inc.
    Generic for: Inspra Tablets, 25 mg and 50 mg

Generic Drug Approvals Archive


2008: Jan | Feb | Mar | Apr | May | Jun | Jul
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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Latest Drug Information Updates

Xenazine
Xenazine (tetrabenazine) is a selective and reversible centrally-acting dopamine depleting drug indicated for the treatment of chorea associated with Huntington's disease.

Cleviprex
Cleviprex is an intravenous, ultrashort-acting calcium channel blocker under development for the treatment of severely elevated blood pressure in the hospital setting when oral therapy is not feasible or desirable.

Stavzor
Stavzor is delayed-release valproic acid formulated in the EnteriCare enteric soft gelatin capsule delivery system designed to minimize GI adverse events. Stavzor is indicated for the treatment of manic episodes associated with bipolar disorder, adjunctive therapy in multiple seizure types (including epilepsy), and prophylaxis of migraine headaches.

Navstel
Navstel is a balanced salt ophthalmic solution for use as an intraocular irrigation during surgical procedures involving perfusion of the eye.

Eovist
Eovist (gadoxetate disodium) is a gadolinium-based contrast agent for intravenous use in T1-weighted magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adults with known or suspected focal liver disease.

Evolence
Evolence is a collagen-based structural dermal filler for the correction of moderate to deep facial wrinkles and folds, such as nasolabial folds.

Kinrix
Kinrix [Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine] is a combination vaccine for protection against diphtheria, tetanus, pertussis and polio diseases in children.

Durezol
Durezol (difluprednate ophthalmic emulsion) is a topical steroid for the treatment of postoperative ocular inflammation and pain.

PrandiMet
PrandiMet (repaglinide and metformin HCl) is a fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin) and insulin sensitizer, metformin, indicated for the treatment of type 2 diabetes.

Pentacel
Pentacel is a combination vaccine indicated for active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive disease due to Haemophilus influenzae type b in children 6 weeks through 4 years of age.

Trivaris
Trivaris (triamcinolone acetonide) is a glucocorticoid corticosteroid delivered via intravitreal injection for the treatment of sympathetic ophthalmia, temporal arteritis, uveitis, and ocular inflammatory conditions unresponsive to topical corticosteroids.

Entereg
Entereg (alvimopan) is a peripherally-acting mu opioid receptor antagonist used to help patients regain gastrointestinal (GI) function earlier following bowel resection surgery.

OraVerse
OraVerse is a dental anesthetic reversal agent that accelerates the return to normal sensation and function following dental procedures.

Aplenzin
Aplenzin is a once-daily formulation of bupropion hydrobromide indicated for the treatment of depression in adults.

Cimzia
Cimzia is a PEGylated anti-TNF (tumor necrosis factor) biologic therapy for the treatment of moderately to severely active Crohn’s disease in adults.

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