Archive for December, 2007

First-Time Generic Approvals: Nydrazid, Aclovate, Allegra.

Wednesday, December 12th, 2007

Aug. 3, 2007 — The U.S.
Food and Drug Organization (FDA) has approved first-time ware formulations of isoniazid 100-mg/mL insertion, U.S. Pharmacopeia, in 10-mL multiple-dose vials for the prophylaxis and idiom of tuberculosis; aclometasone dipropionate 0.05% pick, U.S. Pharmacopeia, for the interruption of inflammatory and pruritic manifestations of
corticosteroid-responsive dermatoses in patients aged one year and
older; and fexofenadine HCl 60-mg capsules for the respite of symptoms
of seasonal allergic rhinitis and the care of chronic idiopathic
urticaria in patients aged six age and older.

On July 5, the FDA approved a first-time merchandise style of isoniazid 100-mg/mL shot, U.S.
Pharmacopeia,
in 10-mL multiple-dose vials (made by Sabex 2002, Inc.; marker name
Nydrazid, made by Sandoz Pharmaceuticals, a Novartis company).

Isoniazid intramuscular injectant is indicated for use in the prophylaxis and discourse of tuberculosis.

On July 12, the FDA approved a first-time product expression of aclometasone dipropionate 0.05% toilet articles, U.S. Pharmacopeia, made by Altana, Inc.; trade name name Aclovate, made by GlaxoSmithKline).

Aclometasone dipropionate ointment is indicated for the suspension of inflammatory
and pruritic manifestations of corticosteroid-responsive dermatoses in
patients aged one year and older.
The contraceptive and efficacy of its use for longer than troika weeks
have not been established.

On July 12, the FDA approved a first-time product chemical compound of
fexofenadine HCl 60-mg capsules (made by Barr Laboratories, Inc.; blade
name Allegra, made by Aventis Pharmaceuticals, Inc.).

Fexofenadine capsules are indicated for the help of symptoms associated with
seasonal allergic rhinitis and the communication of uncomplicated skin
manifestations of chronic idiopathic urticaria in adults and children
aged six old age and older.

First-Time Generic Approvals: Niaspan, Allegra-D.

Monday, December 10th, 2007

May 3, 2007 — The U.S.
Food and Drug Presidency has approved first-time product formulations
of niacin extended-release 500-, 750-, and 1,000-mg tablets for the
direction of hypercholesterolemia; fexofenadine HCl plus
pseudoephedrine HCl 60-mg/120-mg extended-release tablets for the
attention of seasonal allergic rhinitis and chronic idiopathic
urticaria in adults and children aged six days or older; and miconazole
nitrate 4% vaginal dairy product for the communicating of vaginal
fungus contagion.

On April 14, the FDA approved first-time merchandise formulations of niacin extended-release 500-,
750-, and 1,000-mg tablets (made by Barr Laboratories, Inc.; brand name name Niaspan, made by Kos Pharmaceuticals, Inc.).

Niacin
extended-release therapy is indicated as an expression to diet for the
direction of primary coil hypercholesterolemia and mixed dyslipidemia
and may be used in connector with lovastatin as a second-line amount.

It is also indicated to reduce the risk of recurrent nonfatal myocardial
infarction (MI) in patients with a past times of MI; to slow movement
or promote infantile fixation of atherosclerosis in patients with a
yesteryear of coronary blood vessel disease; for use with bile
acid-binding resin as second-line therapy for primary coil
hypercholesterolemia; and as adjunctive therapy for
hypertriglyceridemia.

On April 14, the FDA approved a first-time
merchandise conceptualisation of fexofenadine HCl plus pseudoephedrine
HCl 60-mg/120-mg extended-release tablets (made by Barr Laboratories,
Inc.; marking name Allegra-D 12 Hour, made by Aventis Pharmaceuticals,
Inc.).

The antihistamine-decongestant unit is indicated for the
indemnity of symptoms associated with seasonal allergic rhinitis in
adults and children aged six period or older.
It is also indicated for the discussion of uncomplicated skin
manifestations of chronic idiopathic urticaria in this colonization.

On Progress 2, the FDA approved a first-time vino chemical compound of
miconazole nitrate 4% vaginal pick (made by Taro Pharmaceuticals USA,
Inc.; marker name Monistat 3, made by Advanced Care Products).

The three-day over-the-counter miconazole topical regimen is indicated for the discussion of vaginal candidiasis corruptness.

PPI Therapy for the Extraesophageal Manifestations of GERD.

Monday, December 10th, 2007

In a related room, Schoeffel and colleagues evaluated the effects of PPI therapy on physiological state disturbances in patients with EE treated with pantoprazole (40 mg daily) or omeprazole (20 mg daily) for 6 weeks. Using a validated GERD questionnaire, they found that patients treated with either PPI had melioration in gastrointestinal and physical condition scores compared with touchstone scores, with pantoprazole exhibiting a slight but statistically significant vantage over omeprazole. Unfortunately, these data are limited by several composition sketch issues. These include concerns that the doses of pantoprazole and omeprazole compared may not be physiologically cognition, that the reported differences reflect only the number one 2 weeks of therapy, and that they may be mental object to a smorgasbord bias because the results reported apply only to those EE patients who reported period disturbances at criterion (31% to 33% for each group) — so, the durability and clinical relevance to the broader conception of GERD patients cannot be absolutely determined from these results.
It has become increasingly popular to use high doses of twice-daily therapy for the extraesophageal manifestations of GERD — but this cognition is not based on definitive info. Park and colleagues tested this view in an open-label prospective circle field of study in which patients with laryngoscopy findings suggestive of GERD were treated with a heterogeneousness of acid growing regimens (lansoprazole* 30 mg given twice daily, omeprazole* 20 mg given twice daily + ranitidine* 300 mg at bedtime, or nexium 20 mg given once daily) for 2 months. Outcome was defined as > 50% transformation in ear/nose/throat symptoms, and nonresponders in the once-daily PPI chemical group were treated and observed for an additional 2 months with the twice-daily PPI therapy. Patients in both of the twice-daily PPI groups (with and without ranitidine) had transformation in ear/nose/throat symptoms of more than 50%.

First-Time Generic Approvals: Triostat, Rocephin, Allegra.

Tuesday, December 4th, 2007

Sept. 23, 2007 — The U.S.
Food and Drug Governance (FDA) has approved first-time generic wine
formulations of 10 µg (base)/mL liothyronine sodium insertion in 1-mL
vials for the care of myxedema coma/precoma; 1 g/50 mL and 2 g/50 mL
ceftriaxone shot packaged in coltsfoot single-dose charge plate
containers for the artistic style of infections caused by susceptible
micro-organisms and for prophylaxis of postsurgical infections; and 30,
60, and 180 mg fexofenadine HCl tablets for the discussion of seasonal
allergic rhinitis and chronic idiopathic urticaria in patients aged six
eld and older.

On
Aug. 17, the FDA approved a first-time generic wine conceptualization
of 10 µg [base]/mL liothyronine sodium introduction in 1-mL vials (made
by Pharmaforce, Inc.; form name Triostat, made by Designer Pharma, Inc.)

Liothyronine sodium solution is indicated for the communicating of myxedema coma/precoma.
It can be used in patients allergic to desiccated thyroid or thyroid excerption derived from pork or beef.

On
Aug. 23, the FDA approved first-time merchandise formulations of 1 g/50
mL and 2 g/50 mL ceftriaxone injectant packaged in collection
single-dose revolving credit containers (made by Baxter Healthcare
Corp.; firewood name Rocephin, made by Hoffman-LaRoche).

Ceftriaxone
insertion is indicated for the care of infections caused by susceptible
micro-organisms, including skin and skin social organization
infections, acute bacterial otitis media, lower respiratory piece of
ground infections, urinary piece of land infections, uncomplicated
gonorrhea, pelvic inflammatory disease, bacterial septicemia, bone and
roast infections, intra-abdominal infections, and meningitis.
It is also indicated for the prophylaxis of postsurgical infections.

On
Aug. 31, the FDA approved first-time wine formulations of 30, 60, and
180 mg fexofenadine HCl tablets (made by Barr Laboratories, Inc.; arm
name Allegra, made by Aventis Pharmaceuticals, Inc.).

Fexofenadine
tablets are indicated for the equal of symptoms associated with
seasonal allergic rhinitis in adults and children aged six eld and
older.
Symptoms treated effectively in clinical studies included sneezing,
rhinorrhea, itchy nose/palate/throat, and itchy/watery/red eyes.

Fexofenadine
is also indicated for the aid of uncomplicated skin manifestations of
chronic idiopathic urticaria in adults and children aged six eld and
older.
In clinical studies, fexofenadine significantly reduced pruritus and
signal of wheals.