Generic Drug Approvals

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

Latest Generic Drug Approvals


First-Time Generic Approvals August 2008

  • Galantamine Tablets USP 4 mg, 8 mg and 12 mg
    Approved: August 28, 2008 Barr Laboratories, Inc.; Alphapharm Pty Ltd.
    Generic for: Razadyne Tablets

Generic Drug Approvals Archive


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MedNotes
Latest FDA Drug Alerts
October 9, 2008
Audience: Pediatric and primary healthcare professionals, consumers [Posted 10/09/2008] FDA notified healthcare professionals and...
October 7, 2008
Audience: Pulmonary care health professionals and patients[UPDATE 10/07/2008] FDA informed healthcare professionals that FDA has...
October 3, 2008
Audience: Healthcare professionals, consumers [Posted 10/03/2008] FDA notified healthcare professionals of a Class I Recall of...
October 2, 2008
Audience: Physical medicine and rehabilitation specialists, anesthesia healthcare professionals, hospital surgical service...
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Latest Drug Information Updates

Cinryze
Cinryze is a C1-esterase inhibitor indicated for routine prophylaxis against angioedema attacks in adolescent and adult patients with Hereditary Angioedema (HAE).

Akten
Akten (lidocaine hydrochloride) Ophthalmic Gel is a topical, ocular anesthetic formulation for use in ocular procedures that require a topical anesthetic agent.

AdreView
AdreView is a diagnostic radiopharmaceutical agent indicated for use in the detection of rare neuroendocrine tumors in children and adults.

Sancuso
Sancuso (granisetron transdermal system) is an anti-emetic transdermal delivery system indicated for the control of nausea and vomiting in patients receiving moderately and/or highly nausea-inducing chemotherapy.

Nplate
Nplate (romiplostim) is a thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

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.

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