Leiter's Cambrian Park Drugs, Inc. (dba Leiter's Compounding Pharmacy), San Jose,
CA
- 483 Issued 03/06/201466 (PDF - 1.3MB)
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
03/26/2014 | Bella Vi | Dietary Supplement | Products contain undeclared Sibutramine and/or combination of Sibutramine and Phenolphthalein | Pure Edge Nutrition, LLC |
By Virgil Dickson
Posted: March 25, 2014 - 3:00 pm ET
The Food and Drug Administration wants drugmakers to change labeling on drugs approved through the accelerated approval pathway so doctors and patients know such approvals could subsequently be revoked.
A new FDA guidance (PDF) seeks to clarify how drugs approved through the accelerated approval pathway should be labeled. The pathway in question is used to expedite the approval of medicines intended to treat serious or unmet needs. For instance, if there is a promising drug for a certain type of cancer that shows some early signs of benefit, that product could receive tentative accelerated approval.
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03/25/2014 | Super Fat Burner, Maxi Gold, and Esmeralda | Dietary Supplement | Unapproved new drug | New Life Nutritional Center |