FDA & Prescription Drugs

• Xenical/Alli Under FDA Investigation After Patient Complaints

  C. Todd Alley | August 27, 2009 2:07 PM | 0 CommentsTampa Bay, FL

  The FDA has begun investigating a potential link between liver damage and Orlistat (obesity drugs marketed as Xenical and Alli). On Monday, the FDA issued an Early Communication report to alert...

• Is Alli Causing Liver Failure?

  Brenda Fulmer | August 26, 2009 4:59 PM | 0 CommentsWest Palm Beach, FL

  So, what is Alli (interestingly pronounced (pronounced al-eye)? It started its life as the weight loss drug Xenical. The FDA approved Xenical as a prescription drug in 1999, and the FDA recently...

• My Alli and Me (an Ode to Glaxo’s Orlistat)

  Armand Rossetti | August 25, 2009 1:57 PM | 1 CommentWest Palm Beach, FL

  Rx to OTC: We’re losing weight, my Alli and me. No doctor’s involved as far's I can see. I'll take two smaller pills instead of one? Since Alli’s available to all and...

• Alli and Xenical Receive FDA Review After Reports of Liver Injury

  Joe Saunders | August 25, 2009 8:49 AM | 0 CommentsSarasota, FL

  The FDA is reviewing diet drugs Alli and Xenical after 32 adverse event reports associated the drugs with liver injury. Alli is manufactured and marketed by GlaxoSmithKline and is available as an...

• Alli Diet Drug Investigated by FDA for Liver Injury

  Joe Saunders | August 24, 2009 10:41 PM | 0 CommentsTampa Bay, FL

  Alli, the over-the-counter weight loss drug manufactured by GlaxoSmithKline and its prescription counterpart Xenical, manufactured by Roche, are being investigated by the FDA after more than two...

• Published Medical Journal Articles Concerning HRT Revealed to Be “Ghostwritten”

  Jim Clark | August 20, 2009 8:00 AM | 0 CommentsTampa Bay, FL

  Recently disclosed court documents reveal that Wyeth, the pharmaceutical giant behind hormone replacement medications Premarin and Prempro, has played a “major role” in 26 scientific...

• FDA’s Top Medical Device Regulator Steps Down, Another Top Official Under Investigation

  C. Todd Alley | August 19, 2009 8:58 PM | 0 CommentsTampa Bay, FL

  As my colleague wrote about in April, the FDA has come under fire from internal dissent over questionable medical device approval. Earlier this month on August 11, Dr. Daniel G. Shultz, the...

• Adderall IR; Adderall XR: Are they from Shire, Barr, Teva, or Ranbaxy?

  Armand Rossetti | August 17, 2009 3:01 PM | 1 CommentWest Palm Beach, FL

  Adderall is in the news today. Barr Laboratories (Barr) recalled lot #311756 of the powerful psychostimulant, indicating that consumers might receive exceedingly potent dosages due to oversized...

• Anabolic Steroids -The consumer, the FDA and the Manufacturer

  Alyssa DiEdwardo | August 10, 2009 6:31 AM | 0 CommentsWest Palm Beach, FL

  Even If the most conscientious consumer sifted through the mountains of available information and then carefully weighed each source of the information prior to making a determination if a...

• Attorneys have played a role in the FDA’s evolving approach to enforcement

  Armand Rossetti | August 07, 2009 9:45 AM | 1 CommentWest Palm Beach, FL

  Today’s headlines are replete with news about the FDA’s recent commitment to stronger enforcement. I suspect that attorneys’ public comments over the years, concerning the...