MEMO OF THE MONTH
MEMO OF THE MONTH SVNTU LABORATORIES, INC 3401 HILLVIEW AVENUE, P.O. BOX 10850 PAL0 ALTO, CALIFORNIA 94303 (415) 855mw TELEX 4997273 SYNTEX PLA September 1991 Dear Doctor: We are sending...
...FDA determined that the campaign misrepresented that Naprosyn has disease-modifying effects in osteoanhritis, based on the results of in-vim and animal studies...
...FDA has determined that Syntex Laboratories, Inc...
...MEMO OF THE MONTH SVNTU LABORATORIES, INC 3401 HILLVIEW AVENUE, P.O...
...This campaign used terms such as “arthroprotective” and “New Evidence of Positive Effects” and involved journal advertisements and activities of OUT sales representatives...
...has engaged in a promotional campaign for NaprosynB (naproxen) that was false or misleading...
...No adequate and well-controlled clinical mals demonstrate that Naprosyn has any disease-modifying effects...
...Sincerely, virgil ihompson President Syntex Laboratories, Inc...
...Naprosyn has been demonstrated to halt the progression of joint degeneration...
...BOX 10850 PAL0 ALTO, CALIFORNIA 94303 (415) 855mw TELEX 4997273 SYNTEX PLA September 1991 Dear Doctor: We are sending you this letter at the request of the Food and Drug A+ninismtion (FDA...
...A remedial advertising program is being instituted by Syntex under an agreement with FJ3A...
...In fact, these in-vitro and animal studies are of unknown value as predktors of Naprosyn’s effects in arthritic patients...
...This promotional campaign was discontinued in May of 1991...
...It also involved ostensibly non-promotional programs such as medical education symposia and a ’JQminute Lifetime Medical Television program...
...See enclosed full prescribing information...
Vol. 23 • December 1991 • No. 12
