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FDA Issues BayerHealthCare Pharmaceuticals, Inc. Warning Letter for Yaz

ROCKVILLE, Md., Oct. 7, 2008--The FDA posted on its website a warning letter to BayerHealthCare Pharmaceuticals, Inc. regarding two 60 second DTC ads for oral contraceptive Yaz. According to the FDA, the ads, "are misleading because they broaden the drug's indication, overstate the efficacy of VAl, and minimize serious risks associated with the use of the drug." Please see the attachments for more information.
 

 

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Latest Drug Information Updates

Qutenza
Qutenza is a capsaicin transdermal patch for the management of pain due to postherpetic neuralgia.

Lysteda
Lysteda (tranexamic acid) is an antifibrinolytic agent for the treatment of women with menorrhagia, heavy menstrual bleeding (HMB), and its accompanying symptoms.

Pennsaid
Pennsaid is a topical non-steroidal anti-inflammatory drug (NSAID) used for the treatment of signs and symptoms of osteoarthritis of the knee.

Istodax
Istodax (romidepsin) a histone deacetylase (HDAC) inhibitor indicated the treatment of cutaneous T-cell lymphoma.

Cervarix
Cervarix (human papillomavirus bivalent (types 16 and 18) is a is a preventative cervical cancer vaccine for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 in girls and young women (aged 10-25).

Votrient
Votrient (pazopanib) is a kinase inhibitor indicated for the treatment of patients with advanced renal cell carcinoma.

Arzerra
Arzerra (ofatumumab) is a CD20-directed cytolytic monoclonal antibody indicated for the treatment of patients with chronic lymphocytic leukemia.

Twynsta
Twynsta (telmisartan/amlodipine) is an angiotensin II receptor blocker (ARB) and a dihydropyridine calcium channel blocker (DHP-CCB) combination product indicated for the treatment of hypertension alone or with other antihypertensive agents.

Berinert
Berinert (C1-esterase inhibitor (human)) is a plasma derived C1 Esterase Inhibitor indicated for the treatment of acute abdominal or facial attacks of hereditary angioedema (HAE) in adult and adolescent patients.

Stelara
Stelara (ustekinumab) is a human monoclonal antibody for the treatment of moderate to severe plaque psoriasis.

Influenza A (H1N1) 2009 Monovalent Vaccine
Influenza A (H1N1) 2009 Monovalent Vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons ages 18 years of age and older against influenza disease caused by pandemic (H1N1) 2009 virus.

Zirgan
Zirgan (ganciclovir ophthalmic gel) is a topical ophthalmic antiviral preparation for the treatment of acute herpetic keratitis (dendritic ulcers).

Vibativ
Vibativ (telavancin) is a bactericidal, once-daily injectable antibiotic for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

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Valturna
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