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Application to FDA for use of active Vitamin D for hemodialysis patients – July 2011

Rockwell Medical Announces Acquisition of Generic Drug Vitamin-D to Treat Secondary Hyperparathyroidism in ESRD Patients

Injectable Calcitriol Will Address Estimated $350M U.S. Dialysis Market; press release

WIXOM, Mich., Jul 26, 2011 (GlobeNewswire via COMTEX) — Rockwell Medical , a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia, announced today that it has acquired an Abbreviated New Drug Application (ANDA) for injectable, active Vitamin-D (Calcitriol) for End Stage Renal Disease (ESRD) patients undergoing hemodialysis. Terms were not disclosed.

Mr. Robert L. Chioini, Chairman and CEO of Rockwell Medical stated that, "We are excited to add another renal drug to our expanding pipeline of products. The new bundled-reimbursement for hemodialysis has provided us an ideal opportunity to leverage our existing operating business with more profitable renal products, and we expect this drug, coupled with our current distribution model, will enable us to penetrate the Vitamin-D market effectively. We view this new drug as incrementally positive and accretive in mid-2012."

About Calcitriol; Active Vitamin-D:

Patients with kidney disease have reduced ability to convert nutritional vitamin-D to active vitamin-D in the body. Lack of active vitamin-D leads to disturbances in bone and mineral metabolism characterized by low levels of calcium in the blood and increased production of parathyroid hormone (secondary hyperparathyroidism). Calcitriol is an active vitamin-D that is used to treat low levels of calcium in the blood of patients whose kidneys or parathyroid glands are not working normally. Active vitamin-D and its analogs are routinely prescribed for the majority of ESRD patients. Injectable Calcitriol, the active form of vitamin-D, has been effectively used for the treatment of secondary hyperparathyroidism.

CLICK HERE for full press release

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Clipped from WikiPedia: Abbreviated New Drug Application

An Abbreviated New Drug Application (ANDA) is an application for a U.S. generic drug approval for an existing licensed medication or approved drug.

The ANDA is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. Electronic submissions of ANDAs have grown by 70% since November 2008.1 The Section IV challenge has been credited with suppressing new drug innovation.2

A generic drug product is one that is comparable to an innovator drug product in dosage form, strength, route of administration, quality, performance characteristics and intended use. All approved products, both innovator and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book).

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) trial data to establish safety and effectiveness. Instead, generic applicants must scientifically demonstrate that their product is bioequivalent (i.e., performs in the same manner as the innovator drug). One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the bloodstream in 24 to 36 healthy volunteers. This gives them the rate of absorption, or bioavailability, of the generic drug, which they can then compare to that of the innovator drug. The generic version must deliver the same amount of active ingredients into a patient's bloodstream in the same amount of time as the innovator drug. The bioequivalence of a drug can be demonstrated by comparing drugs dissolution or transdermal drug absorption in case of topically active drug, in case of systemically active drug blood concentration of that drugs is compared with innovator drugs

Using bioequivalence as the basis for approving generic copies of drug products was established by the Drug Price Competition and Patent Term Restoration Act of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of brand-name drugs without conducting costly and duplicative clinical trials. At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.
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See also VitaminDWiki

Nice comparison of "New Drug Application" and "Abbreviated New Drug Application" 2010

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Should we feel happy or sad about this development?

  • Happy that vitamin D is being used in a application by Big Pharma
  • Sad that the company might get exclusive rights for 7 years if they are awarded orphan drug status and then can charge anything they want
    • Drug is an orphan if it treats < 200,000 people per year in the US

Natural News Feels Sad

  • Big Pharma looks to capitalize on success of vitamin D by turning it into a 'drug' for kidney disease