Caraco Pharmaceutical Labs responds to FDA warning
Although Americans are becoming increasingly aware of toxic chemical exposure from everyday household products like bisphenol A in some baby bottles and lead in some toys, women do not readily connect typical household products with personal chemical exposure and related adverse health effects, according to research from the December issue of the Journal of Health
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Caraco Pharmaceutical Laboratories, Ltd. announced today that it has timely submitted its response to the FDA warning letter that was received on October 31, 2008.
In the warning letter, the FDA requested a response from Caraco within 15 business days, ending November 24, 2008.
As previously disclosed, the warning letter was issued as a follow up to the last FDA inspection of the Company’s manufacturing facility in Detroit, Michigan which was initiated in May 2008. Until the Company’s responses to the observations have been clarified and explanations provided to the satisfaction of the FDA, the FDA may in the near term withhold approval of pending new drug applications listing the facility as the manufacturer. The Company’s sales of current products continue in the normal course of business.
The Company is committed to working cooperatively and expeditiously with the FDA to resolve the matters indicated in its letter. The Company has requested a meeting with the FDA as a follow up to its response. Caraco believes it has addressed the concerns in the warning letter appropriately.
Mylan Inc. has announced that its subsidiary, Mylan Pharmaceuticals Inc., received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Fluoxetine Capsules USP, 10 mg and 20 mg. Fluoxetine Capsules, indicated for the treatment of premenstrual dysphoric disorder (PMDD) are the generic version of Eli Lilly’s
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The U.S. Food and Drug Administration (FDA) announced a Class 1 recall today for two unapproved and uncleared devices whose manufacturers claimed could treat various medical conditions. A Class 1 recall means that there is a reasonable probability that the use of a device will cause adverse health consequences or death. The manufacturers, VIBE Technologies
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Salix Pharmaceuticals, Ltd. has announced that the Company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for balsalazide tablet studied as a treatment of mild-to-moderate active ulcerative colitis in patients 18 years and older. Based on its review, the FDA has determined that
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Schering-Plough Corporation has announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter for SAPHRIS (asenapine) sublingual tablets in the acute treatment of schizophrenia in adults and in the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults as monotherapy. The action letter includes proposed
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Mylan Inc. has confirmed that the company and its subsidiary, Mylan Pharmaceuticals Inc., have been sued by Novartis in connection with Fluvastatin Capsules USP, 20 mg (base) and 40 mg (base), the generic version of Novartis’ Lescol(R) Capsules. Mylan believes it is the first company to file a substantially complete Abbreviated New Drug Application
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