FDA May Pull ProAmatine and it’s Generic from the Market

The Food and Drug Administration may repeal the marketing of a low-blood-pressure drug called midodrine hydrochloride or ProAmatine manufactured by many Companies including Maple Grove-based Upsher-Smith Laboratories.

The said drug, marketed by Shire Development Inc., and as a generic by Apotex Corp., Impax Laboratories, Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith got the approval in 1996, citing its benefits for the treatment of peril disorders.

The drug has come under scrutiny, as the prior sanction was speedy and now the FDA wants to carry out more clinical trials on humans to confirm the effectiveness of the drug. For the first time in history, FDA would nullify the commercialization of a drug.

ProAmatine is prescribed to keep in check orthostatic hypotension, which helps the patient to maintain blood pressure. But, the drug poses some side-effects including fainting and giddiness.

Dr. Norman Stockbridge, Director of the FDA's Cardiovascular and Renal Drugs division stated that they have been demanding from Companies to submit additional data regarding the drug's clinical benefits to patients, but if they do not turn up with the same, a withdrawal of the drug will have to be exercised.

But those patients who are already taking it can continue with the same, as till now, no unfavorable events have been experienced, as expressed by FDA' Spokeswoman Sandy Walsh.

The Companies have to revert back to the FDA in 30 days with their reports, unless the FDA will annul the drug and it's generic from being marketed.