Here is news that came across the wire at 10:45 ish PST
today. I find it a little strange this was released
today. More on that after the message:
Rockville, Md. (Dow JOnes)--The food and Drug administration
issued a warning letter to Vivus Inc. (VVUS) regarding deviations
in the manufacturing of the firm's Muse urethral suppositories.
The warning letter, dated May 29, comes followin and inspection
of Vivus at Paco Pharm. Services., Lakewood, N.J. between
Feb 10 and March 13.
The letter states that severl lot numbers didn not meet
content specifications and corrective actons were not taken
prior to the man. of subsequent lot numbers. Among the cntent
problems cited wer failure to meet dissolution req's
and some products didn't have the required label strength.
The agency said investigations were either not conducted
by the quality unit regarding the above problems, or they
were incomplete.
The warning letter also cites the company for inadequate
complaint handling.
The agency acknowledged receiving a respons from VVUS dated march
21 to the list of inspectional observations issued to the
faciity on March 13. The FDA said further written responses were
also evaluated and appear satisfactory. However, the FDA
said it will confirm the acutal corrective actions and
compliance with good man. practice during the next
inspection of their facility.
Co. officials said they have requested a re-inspection
of the facility. The VVUS plant has continued to produce
Muse throughout this period and production and resulting
sales have continued at the facility's max. current
capacity, a release by company official said.
VVUS develops therapeutic systems for the treatment of
erectyle dysfunction.
(END) DOW JONES NEWS 7-01-97
1:26 PM
To me, this seems like a non-event. The letter was
Dated May 29 and it was in regards to the first inspection
which we already new about. I know the reinspection is
due very soon, at least I think so. Why did this come
out today, and why did it drop the stock 2 points. Do
people think this was the reinspection? It looks like
a good buying time.
I look foward to reading coments,
Very Curious,
Colby
P.S. Sorry for any typos in the news. I had to type it
all in. Don't have a scanner. |
