SILVER SPRING, MD — The Food and Drug Administration announced Thursday the full regulatory approval of Remordizol, a twice-daily oral tablet indicated for the management of moderate-to-severe chronic joint inflammation, praising the drug's clinical profile as "largely encouraging" despite the medication's official side-effect disclosure listing the patient's original condition as item forty-seven on a forty-seven-item list.

The approval, granted after three Phase III trials involving roughly 4,200 participants, authorizes Veltracor Pharmaceuticals to begin distributing Remordizol to U.S. patients immediately. The drug's prescribing information, which unfolds to approximately the size of a standard road map, advises patients to contact their doctor if they experience nausea, photosensitivity, temporary blindness, a persistent sensation of being watched, involuntary humming, paradoxical hair thickening, localized numbness in the left earlobe, or, at item forty-seven, "moderate-to-severe chronic joint inflammation."

"The return of the index condition is listed under Uncommon Side Effects, which we define as occurring in fewer than ten percent of users. That means ninety percent of patients will not re-develop the disease Remordizol is treating. Those are genuinely good numbers."

Dr. Fenwick Prall, Associate Deputy Director of the FDA's Office of Circular Therapeutic Outcomes, acknowledged at a press conference that the entry had "raised some eyebrows internally" but emphasized that the benefit-risk profile remained favorable when items one through forty-six were weighted appropriately.

"We look at the totality of the data," Dr. Prall said. "Items one through forty-six represent a manageable constellation of effects. Item forty-seven, yes, is the disease. But it is listed last, which should provide some comfort."

Veltracor spokesperson Manda Cleese said the company was "thrilled" by the approval and stressed that Remordizol had outperformed placebo in every primary endpoint of the trials, a claim that holds even after accounting for the subset of patients who finished the study in precisely the condition in which they began it.

The drug's television advertising campaign, already in production, is reported to be thirty seconds long. Sixteen of those seconds are allocated to the side-effect voiceover. Network standards require the narrator to read item forty-seven at the same speed as items one through forty-six, with no tonal change.

Patient advocacy group Joints Forward issued a cautiously optimistic statement, noting that Remordizol represented "a new option" for sufferers and that members would evaluate it "alongside existing therapies, most of which do not list themselves as a known complication."

Remordizol will carry a list price of $847 per month before insurance. A patient assistance program is available for those who qualify, whose application form is four pages long and includes the question: "Are you currently experiencing moderate-to-severe chronic joint inflammation?" Applicants who answer yes are advised to consult their doctor before completing the remainder of the form.

The drug is expected to reach pharmacy shelves within sixty days.