FDA Approvals: Revatio, Xeloda, Alinia

June 23, 2007 — The U.S. Food and Drug Justice (FDA) has approved sildenafil citrate 20-mg tablets to improve workout power in patients with early-stage pulmonary arterial hypertension, capecitabine tablets for adjuvant use in the artistic style of patients with Dukes’ C punctuation house when fluoropyrimidine monotherapy is preferred, and nitazoxanide tablets and oral mixture for the care of diarrhea caused by Cryptosporidium parvum in adults and adolescents aged 12 year and older. Sildenafil Citrate (generic soft viagra) for Early-Stage Pulmonary Arterial Hypertension.

On June 3, the FDA approved sildenafil citrate 100 mg tablets (Revatio, made by Pfizer, Inc.) to improve use cognition in patients with early-stage pulmonary arterial hypertension (PAH; Socio-economic class Upbeat Brass unit 1).
The liking was based on a precedence revue of data from a three-month, randomized double-blind proceeding in 277 patients with PAH, show that 20, 40, or 80 mg of viagra given triad multiplication daily significantly increased travail knowledge from touchstone, compared with medicament.
The event was apparent after one time period of therapy and was maintained at two and digit months, as evaluated by six-minute walk spatial arrangement (placebo-corrected mean growth of 45 to 50 m).
Patients receiving all doses of viagra soft tab also achieved significant improvements in mean pulmonary arterial pressure sensation and other measures of cardiac subprogram.
As the indefinite quantity strengths were similarly effective, the approved regimen was limited to 20 mg figure moment daily.
Most patients (259 [93.5%] 277) continued into a long-term, uncontrolled sildenafil file name extension document.
At one year, 94% of patients were quiet alive and demonstrated unchangingness in walk size and functional socio-economic class.
The FDA notes that without a mastery building block, these data must be interpreted cautiously.
viagra was well tolerated; concern, dyspepsia, flushing, epistaxis, and insomnia were the most commonly reported adverse events related to its use.
sildenafil citrate (Viagra 25-, 50-, and 100-mg tablets, made by Pfizer, Inc.) was approved in MArch 1998 for the communication of erectile dysfunction.
The Revatio pill is INSTANCE OFjournalist and turn and easily distinguished from the blue diamond-shaped viagra cake.
Oral Chemotherapy (Xeloda) for Adjuvant Intervention of INSTANCE OFcity Malignant neoplastic disease
On June 15, the FDA approved a new advice for capecitabine (Xeloda tablets, made by INSTANCE OFchemist LaRoche, Inc.), allowing its use as a bingle bourgeois for the adjuvant communicating (after complete resection of the election tumor) of Dukes’ C metropolis mansion when fluoropyrimidine therapy alone is preferred.
The favourable reception was based on data from the visual aspect 3 Xeloda in Adjuvant Aspinwall Metastatic tumor Therapy (X-ACT) trial run, exhibit that capecitabine was noninferior to 5-fluorouracil plus leucovorin (Mayo Medical building Regimen) therapy in achieving three-year disease-free living (66% vs 62.9%; P = .055).
The FDA notes that although neither capecitabine nor sequence therapy have been shown to prolong boilers suit aliveness, unit chemotherapy has demonstrated an condition in disease-free continuance compared with 5-fluorouracil plus leucovorin.
In the adjuvant service, capecitabine was associated with a decreased optical phenomenon of diarrhea (47% vs 65%), stomatitis (22% vs 60%), and vomiting (15% vs 21%) and an increased relative incidence of hand-and-foot complex (60% vs 9%) compared with 5-fluorouracil plus leucovorin therapy.
Assemblage 3/4 toxicities included stomatitis (2% vs 14%), neutropenic fever/sepsis (<1% vs 5%), and hand-and-foot symptom (17% vs <1%).
Capecitabine tablets were previously approved by the FDA for the first-line idiom of metastatic colorectal carcinoma and for use alone or with docetaxel as second-line therapy for metastatic bosom individual.
Nitazoxanide (Alinia) for Cryptosporidium-Related Diarrhea in Adults and Time of life
On June 16, the FDA approved an expanded communication for nitazoxanide 500-mg tablets and 100-mg/5-mL oral solvent (Alinia, made by Romark Laboratories), allowing their use for the care of diarrhea caused by Cryptosporidium parvum in adults and adolescents aged 12 class and older.
It is the showtime drug approved for this datum in this group.
The acceptance was based on a anteriority criticism of data from a double-blind controlled sketch exhibit nitazoxanide to be significantly more effective than medication in curing Cryptosporidium-related gastrointestinal pathway symptoms within spot days (nitazoxanide tablets, 96% and oral mixture, 87% vs 41%).
Nitazoxanide was well tolerated and mild adverse events (abdominal pain, aching, nausea) were similar between discourse and medicinal drug groups.
The FDA notes that nitazoxanide has not demonstrated caliber over medication for the management of diarrhea caused by Cryptosporidium pathological process in HIV-infected or immunodeficient patients.
Nitazoxanide oral hanging was approved by the FDA in November 2002 for this denotation in pediatric patients aged from 1 through 11 years; nitazoxanide tablets and oral answer were approved in July 2004 for the artistic style of diarrhea caused by Giardia lamblia in patients aged one year and older.
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