Prasco announces agreement with Shire for the Authorized Generic of FOSRENOL® (lanthanum carbonate)

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Oct 17, 2013, 09:19 ET

CINCINNATI, Oct. 17, 2013 /PRNewswire/ -- Prasco Laboratories announced today it has signed an exclusive distribution and supply agreement with Shire for the Authorized Generic of FOSRENOL® (lanthanum carbonate) Chewable Tablets. As part of the agreement, Prasco will market Lanthanum Carbonate Chewable Tablets in the U.S. in 500 mg, 750 mg, and 1000 mg strengths under the Prasco label in response to the first generic entrant.

"Today's announcement is the latest example of Prasco and Shire working together to continue providing high-quality prescription options to consumers," stated Prasco president and chief operating officer David Vucurevich, R.Ph. "Patients and customers alike benefit from Shire's commitment to maintaining the supply of brand-identical medication through the Prasco Authorized Generic business model," Vucurevich concluded.

Lanthanum Carbonate Chewable Tablets are AB-rated and substitutable for the brand FOSRENOL Chewable Tablets. FOSRENOL is a phosphate binder indicated to reduce serum phosphate in patients with end stage renal disease (ESRD). For more information on Lanthanum Carbonate Chewable Tablets, including the Full Prescribing Information, visit prasco.com. Please click here for Full Prescribing Information for FOSRENOL (lanthanum carbonate)

About Prasco Laboratories – Prasco, the Authorized Generic Company, is the privately held healthcare company located in Mason, Ohio. The leader in Authorized Generics, Prasco has more Authorized Generic partnerships than any other company. Established brand companies rely on Prasco to bring their brand products to the generic marketplace as Authorized Generics, which offers alternatives to consumers and pharmacists. For more information, visit prasco.com.

INDICATION

FOSRENOL (lanthanum carbonate) is indicated to reduce serum phosphate in patients with end stage renal disease (ESRD).

IMPORTANT SAFETY INFORMATION

FOSRENOL is contraindicated in patients with bowel obstruction, ileus, and fecal impaction.
Serious cases of gastrointestinal obstruction, ileus, and fecal impaction have been associated with lanthanum use, some requiring surgery or hospitalization. Risk factors include altered gastrointestinal anatomy, hypomotility disorders, and concomitant medications.
Instruct patients to chew or crush the tablet completely to reduce the risk of serious adverse gastrointestinal events. Advise patients with poor dentition that they may crush tablets completely. Advise patients to take FOSRENOL with or immediately after meals.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease, or bowel obstruction were not included in FOSRENOL clinical studies.
FOSRENOL has radio-opaque properties and may give the appearance typical of an imaging agent during abdominal X-ray procedures.
The most common adverse reactions seen with FOSRENOL in clinical trials included nausea, vomiting, diarrhea, and abdominal pain.
There is potential for FOSRENOL to interact with:
- compounds that bind to cationic antacids (ie, aluminum-, magnesium-, or calcium-based)
- oral quinolone antibiotics
- thyroid hormone replacement therapy
These concomitant medications should be dosed separately from FOSRENOL to avoid drug interactions. See the Full Prescribing Information for dosing recommendations.
FOSRENOL is Pregnancy Category C. FOSRENOL is not recommended for use during pregnancy. It is not known whether FOSRENOL is excreted in human milk. Use caution when prescribing FOSRENOL to a nursing woman.
The safety and efficacy of FOSRENOL in pediatric patients have not been established. The use of FOSRENOL in this population is not recommended.