First-Time Generic Approvals: Cipro IV, Surmontil, Lamictal

Yael Waknine

September 06, 2006

September 6, 2006 — The US Food and Drug Administration (FDA) has approved first-time generic formulations for ciprofloxacin 200-mg/20-mL, 400-mg/40-mL, and 1200-mg/20-mL single-dose vials in the treatment of certain infections, including exposure to inhalational anthrax; trimipramine maleate 25-mg, 50-mg, and 100-mg capsules for the treatment of depression; and lamotrigine 25-mg, 100-mg, 150-mg, and 200-mg tablets for the treatment of seizures and bipolar disorder.


Generic Ciprofloxacin Injection (Cipro IV) for Inhalational Anthrax and More


On August 28, the FDA approved 6 first-time generic formulations for ciprofloxacin 10-mg/mL injection (brand name Cipro IV
, made by Bayer AG).

The generic product will be available in 200-mg/20-mL and 400-mg/40-mL single-dose vials from Abraxis Pharmaceutical Products; Sicor Pharmaceuticals, Inc; Hospira, Inc; and Bedford Laboratories; 1200-mg/20-mL single-dose vials will also be manufactured by Bedford.

Ciprofloxacin intravenous infusion is indicated for the treatment of infections caused by susceptible microorganisms. In adults, it may be used in combination with piperacillin
sodium as empirical therapy for febrile neutropenic patients and for the treatment of urinary tract infections, lower respiratory tract infections, nosocomial pneumonia
, skin and skin structure infections, bone-joint infections, complicated intra-abdominal infections, acute sinusitis
, and chronic bacterial prostatitis
.

It is also indicated for the treatment of pediatric patients aged 1 year and older with complicated urinary tract infections and pyelonephritis
and to reduce the incidence or progression of disease from exposure to inhalational anthrax in adults and children.


Generic Trimipramine Capsules (Surmontil) for Depression


On August 2, the FDA approved first-time generic formulations for trimipramine maleate 25-mg, 50-mg, and 100-mg capsules (made by Amide Pharmaceutical, Inc; brand name Surmontil
, made by Odyssey Pharmaceuticals, Inc).

Trimipramine capsules are indicated for the treatment of depression.


Generic Lamotrigine Tablets (Lamictal) for Seizures and Bipolar Disorder


On August 30, the FDA approved first-time generic formulations for lamotrigine 25-mg, 100-mg, 150-mg, and 200-mg tablets (made by Teva Pharmaceuticals USA; brand name Lamictal
, made by GlaxoSmithKline).

Lamotrigine is indicated as adjunctive therapy for partial seizures and generalized seizures of Lennox-Gastaut syndrome
in patients aged 2 years and older.

It is also indicated for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug
, and for the maintenance treatment of bipolar I disorder to delay the occurrence of mood episodes in patients treated for acute mood episodes with standard therapy.

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