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Details for Generic Name: efavirenz

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Summary for Generic Name: efavirenz

Drug Master File Entries: see list22
Suppliers: see list2
Therapeutic Class:Antivirals

Tentative approvals for EFAVIRENZ

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG
<disabled><disabled>TABLET; ORAL100MG
<disabled><disabled>TABLET; ORAL600MG; 300MG; 300MG

Clinical Trials for: efavirenz

Sustiva Levels With Use of a Gel Capsule
Status: Completed Condition: HIV; HIV Infections

Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz
Status: Active, not recruiting Condition: Hyperlipidemia; HIV

Drug-Drug Interaction Study Between Fenofibric Acid and Efavirenz
Status: Completed Condition: Healthy

Efavirenz Comparative Bioavailability
Status: Completed Condition: Healthy

Pharmacokinetic and Pharmacodynamic Interactions Between the Cholesterol-lowering Ezetimibe and the Non-nucleoside Reverse Transcriptase Inhibitor Efavirenz During Chronic Treatment in Healthy Volunteers With Reference to Intestinal Expression of CYP3A4, UGT1A1, ABCB1 and ABCC2
Status: Completed Condition: Pharmacokinetics; Drug Interactions; Pharmacodynamics; Intestinal Transporter Expression

Effects of CYP2B6 Genetic Polymorphisms on Efavirenz Pharmacokinetics
Status: Completed Condition: HIV

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Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes6,939,964*PED<disabled>Y<disabled>
efavirenz; emtricitabine; tenofovir disoproxil fumarate
TABLET;ORAL021937Jul 12, 2006RXYes6,639,071*PED<disabled>Y<disabled>
Bristol Myers Squibb
CAPSULE;ORAL020972Sep 17, 1998RXYes5,663,169*PED<disabled>Y<disabled>
Bristol Myers Squibb
CAPSULE;ORAL020972Sep 17, 1998RXNo6,238,695*PED<disabled>Y<disabled>
Bristol Myers Squibb
TABLET;ORAL021360Feb 1, 2002DISCNNo6,639,071*PED<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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