First-Time Generic Approvals: Sandostatin, Dantrium, Grifulvin V,...

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Nina

First-Time Generic Approvals: Sandostatin, Dantrium, Grifulvin V,

Depo-Medrol

Yael Waknine

Medscape Medical News 2005. © 2005 Medscape

April 13, 2005 — The U.S. Food and Drug Administration (FDA) has

approved first-time generic formulations of octreotide acetate

preservative-free injection for the treatment of acromegaly and for

symptomatic treatment of metastatic carcinoid and vasoactive intestinal

peptide-secreting tumors; dantrolene sodium capsules for controlling

manifestations of clinical spasticity due to upper motor neuron

disorders and for the prevention of malignant hyperthermia;

griseofulvin oral suspension for the treatment of infections caused by

susceptible dermatophytes; and methylprednisolone acetate injectable

suspension for the treatment of conditions requiring injectable

corticosteroid therapy.

Generic Octreotide (Sandostatin) for Acromegaly, Symptomatic Treatment

of Certain Tumors

On March 28, the FDA approved generic formulations of octreotide

acetate 0.05 mg/mL, 0.1 mg/mL, and 0.5 mg/mL preservative-free

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.

Generic Dantrolene Sodium Capsules (Dantrium) for Spasticity,

Prevention of Malignant Hyperthermia

On March 1, the FDA approved first-time generic formulations of

dantrolene sodium 25-, 50-, and 100-mg capsules (made by Impax

Laboratories, Inc; brand name Dantrium, made by Proctor & Gamble Co).

Dantrolene sodium capsules are indicated for controlling manifestations

of clinical spasticity resulting from upper motor neuron disorders such

as spinal cord injury, stroke, cerebral palsy, or multiple sclerosis.

It is also indicated for use in preventing recurrence after treatment

of an acute episode and preventing or attenuating the development of

malignant hyperthermia in susceptible patients who require anesthesia

and/or surgery.

Generic Griseofulvin Oral Suspension (Grifulvin V) for Ringworm and

Onychomycosis

On March 2, the FDA approved a first-time generic formulation of

griseofulvin 125 mg/5 mL oral suspension (made by Stiefel Laboratories,

Inc; brand name Grifulvin V, made by & , Inc).

Griseofulvin 125 mg/5 mL oral suspension is indicated for the treatment

of infections caused by susceptible dermatophytes.

Generic Methylprednisolone Acetate Injectable Suspension (Depo-Medrol)

for Conditions Requiring Systemic Steroid Therapy

On Feb. 23, the FDA approved first-time generic formulations of

methylprednisolone acetate 40 mg/mL and 80 mg/mL injectable suspension

(made by Sicor Pharmaceuticals, Inc; brand name Depo-Medrol, made by

Pfizer, Inc).

Methylprednisolone acetate injectable suspension is indicated for the

treatment of a variety of conditions requiring administration of

injectable corticosteroids, including acute lymphocytic leukemia,

adrenocortical insufficiency, allergic rhinitis, atopic dermatitis,

inflammatory bowel disease, transplant rejection, and rheumatoid

arthritis.

Reviewed by D. Vogin, MD

http://www.medscape.com/viewarticle/503062