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HIV Treatment Information for Pregnant Women
30 Jan 2025 20:04 GMT
… and are virologically suppressed (HIV-1 RNA less than 50 … and Postpartum
Human Data
Intelence Label
Pifeltro
doravirine 100 mg … available for the approved treatment dose of 600 mg …
CD4-directed post-attachment HIV-1 inhibitor
Intravenous Injection
…
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Camzyos interactions: Alcohol, medications, and other factors
14 Aug 2024 18:11 GMT
… HIV drugs, such as:
cobicistat (Tybost)
nelfinavir (Viracept)
ritonavir (Norvir)
certain antidepressants … HIV drugs, such as:
efavirenz
etravirine (Intelence)
certain cancer drugs, … drugs, talk with your doctor about your treatment options.
If your doctor …
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Human medicines European public assessment report (EPAR): Intelence, etravirine, Date of authorisation: 28/08/2008, Revision: 31, Status: Authorised
13 Aug 2024 17:26 GMT
… taking Intelence together with other HIV medicines had undetectable levels of HIV, compared … placebo (a dummy treatment) plus the other HIV medicines. These findings were … of treatment. After 48 weeks of taking Intelence together with other HIV medicines, …
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In Berger Montague Whistleblower Case, Janssen Found Liable for Illegal Off-Label Promotion and Marketing of Two HIV/AIDS-Treatment Drugs - Judgment Could Exceed $1B
17 Jun 2024 19:32 GMT
… of two of its HIV/AIDS-treatment drugs, in violation of … government for its drugs, Prezista and Intelence, and awarded … against the billion-dollar pharmaceutical company Janssen. In 2012 … and Drug Administration (FDA) and for uses not medically reasonable …
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Final Judgment Could Exceed $1 Billion in HIV Drug False Claims Case Against Janssen
19 Jun 2024 18:06 GMT
… promotion of the HIV drugs Prezista and Intelence.
Janssen hired two … during the six-week trial demonstrated that Janssen … submission of drug claims to Medicare, ADAP, and Medicaid for … drugs by promoting their use beyond their labels and misleading doctors …
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J&J to seek appeal of $150M verdict in long-spanning HIV meds off-label marketing case
17 Jun 2024 19:35 GMT
… promotions of its HIV meds Prezista and Intelence.
More specifically … J&J Innovative Medicine, was initially accused … dangerous contradiction from the drug’s FDA-approved label, which … Intelence was safe and effective for once-daily dosing and in treatment …
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Non-Compliance Letters under 505B(d)(1) of the Federal Food, Drug, and Cosmetic Act
13 Sep 2023 02:34 GMT
… )
Janssen Research & Development, LLC
Intelence (etravirine) 200 mg, 100 mg … /30/14)
The Medicines Company
Cleviprex (clevidipine) IV emulsion … )*
Egalet US, Inc. (formerly Luitpold Pharmaceuticals, Inc.)
Sprix (ketorolac tromethamine) Nasal …
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2021 First Generic Drug Approvals
03 Mar 2023 17:52 GMT
… Hydrochloride Cream, 1%
Taro Pharmaceuticals Inc.
Rhofade (Oxymetazoline Hydrochloride … mg
Amneal EU, Limited
Intelence (Etravirine) Tablets, 25 … For the treatment of HIV-1 infection in treatment-experienced … are to be managed medically and those undergoing …
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Explaining HIV and AIDS
25 Jul 2022 16:22 GMT
… an advanced stage of HIV.
Doctors identify AIDS as having a … look at HIV treatments and medications for prevention.
Emergency HIV pills: PEP
Anyone … etravirine (Intelence)
nevirapine (Viramune)
Chemokine coreceptor antagonists
These drugs prevent HIV from …
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Reviews of Pediatric Studies Conducted under BPCA and Pediatric assessments conducted under PREA from 2012 – present
18 Sep 2024 16:26 GMT
Drug Sponsor
Sponsor
Medical Review
Clinical … Medical (PDF - 2 MB)
None
None
PREA
Etravirine - Intelence … Golimumab - Simponi
Janssen Biotech, Inc.
Medical (PDF - 3.1 … Boehringer Ingelheim Pharmaceuticals, Inc.
Medical (PDF -11.9MB)
Medical Addendum (PDF …