First-Time Generic Approvals: Clozaril, Ultracet, Sandostatin, Elocon

Yael Waknine

May 17, 2005

May 17, 2005 — The U.S. Food and Drug Administration (FDA) has approved a first-time generic formulation and first-time 50-mg dosage strength of clozapine tablets for the management of schizophrenia and reduction of associated suicide risk and first-time generic formulations of tramadol HCl plus acetaminophen 37.5-mg/325-mg tablets for the management of moderate to severe pain; octreotide acetate 0.2-mg/mL and 1-mg/mL injections for the treatment of acromegaly and for symptomatic treatment of metastatic carcinoid and vasoactive intestinal peptide-secreting tumors; and mometasone furoate topical solution, USP 0.1%, for the symptomatic relief of dermatoses.

First-Time 50-mg Generic Clozapine (Clozaril) for Schizophrenia



On April 25, the FDA approved a first-time generic formulation and first-time 50-mg dosage strength of clozapine tablets (made by Ivax Pharmaceuticals, Inc; reference drug, Clozaril, made by Novartis Pharmaceuticals Corp).

Previously approved generic formulations of clozapine include 12.5-, 25-, and 100-mg strengths. The brand name formulation is available in 25- and 100-mg strengths.

Clozapine is indicated for the management of treatment-resistant schizophrenia and to reduce the risk of recurrent suicidal behavior in patients with schizophrenia or schizoaffective disorder.

Generic Tramadol Plus Acetaminophen (Ultracet) for Pain Management



On April 21, the FDA approved a first-time generic formulation of tramadol HCl plus acetaminophen 37.5-mg/325-mg tablets (made by Kali Laboratories, Inc; brand name Ultracet, made by Ortho McNeil Pharmaceutical, Inc).

Tramadol HCl plus acetaminophen tablets are indicated for the management of moderate to moderately severe pain in adults.

Generic Octreotide (Sandostatin) for Acromegaly, Symptomatic Treatment of Certain Tumors



On April 8, the FDA approved generic formulations of octreotide acetate 0.2-mg/mL (base) and 1-mg/mL (base) injection (made by Bedford Laboratories, Inc; brand name Sandostatin, made by Novartis Pharmaceuticals Corp).

Octreotide acetate injection is indicated for the reduction of growth hormone and somatomedin C blood levels associated with acromegaly, for the suppression or inhibition of flushing and diarrhea episodes associated with metastatic carcinoid tumors, and for the treatment of profuse watery diarrhea associated with vasoactive intestinal peptide–secreting tumors.

First-time generic formulations of preservative-free octreotide acetate 0.05-mg/mL, 0.1-mg/mL, and 0.5-mg/mL injections were approved by the FDA on March 28.

Generic Mometasone Furoate Topical Solution (Elocon) for Dermatoses



On April 16, the FDA approved a first-time generic formulation of mometasone furoate topical solution, USP 0.1% (made by Agis Industries, Ltd; brand name Elocon, made by AG Schering Corp).

Mometasone furoate topical solution is a medium potency corticosteroid indicated for the relief of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. It is not recommended for use in patients aged younger than 12 years because the safety and efficacy of the product have not been determined in this population.

Reviewed by Gary D. Vogin, MD

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.
Post as:

processing....