Instituto Bioclon

The Instituto Bioclon S.A. de C.V. (Bioclon Institute) was formed in 1990 to research and develop F(ab’)2 antivenoms. In May 6, 2015 they received approval from the FDA to commercialize ANAVIP[1] becoming their second drug approved by the FDA after ANASCORP.[2] Both are commercialized in the US by Rare Disease Therapeutics, Inc.[3] The company is performing clinical trails to get approval for a third drug, ANALATRO, designed to treat black widow spider envenomation.[4][5]

Instituto Bioclon S.A. de C.V.
Private
IndustryBiomedicine
Founded1990
Headquarters
Mexico City
,
Mexico
ServicesAntivenom research and development
ParentSilanes Laboratories

Operations

The Instituto Bioclon is located in Mexico City, Mexico and has a Certificación Internacional de Buenas Prácticas de Manufactura (International Certificate for Good Manufacturing Practices) which was granted to Bioclon by the Instituto Nacional de Vigilancia de Alimentos y Medicamentos, (INVIMA) (National Food and Drug Monitoring Institute), of the Ministry of Health and Social Protection of Colombia, as well as by COFEPRIS, in Mexico.

Products

The Bioclon Institute is the only Mexican company that has obtained an "orphan drug" status from the Food and Drug Administration (FDA) of the United States for its products.

References
  1. ANAVIP FDA Approval |https://www.fda.gov/biologicsbloodvaccines/bloodbloodproducts/approvedproducts/licensedproductsblas/fractionatedplasmaproducts/ucm446151.htm%7C
  2. ANASCORP FDA Approval https://www.fda.gov/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/ucm266723.htm
  3. "Rare Disease Therapeutics, Inc. // Products". Retrieved 2019-04-14.
  4. "Rare Disease Therapeutics, Inc. // Research". Retrieved 2019-04-14.
  5. "Black Widow Spider Antivenin for Patients With Systemic Latrodectism - Full Text View - ClinicalTrials.gov". clinicaltrials.gov. Retrieved 2019-04-14.
  6. Deborah Silverstein; Kate Hopper (5 September 2014). Small Animal Critical Care Medicine. Elsevier Health Sciences. p. 916. ISBN 978-0-323-24352-0.

See also
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