-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, OWc1TJx7+/QK0JfqqlgxsGl863fUMnrUa/TJeTmqekuB8Ib1NXhE0VRgZjwDbw0A 4e5SLUo6fM2jLsBnUGtPGQ== 0001104659-08-026537.txt : 20080424 0001104659-08-026537.hdr.sgml : 20080424 20080424161313 ACCESSION NUMBER: 0001104659-08-026537 CONFORMED SUBMISSION TYPE: 6-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20080423 FILED AS OF DATE: 20080424 DATE AS OF CHANGE: 20080424 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BIOVAIL CORP INTERNATIONAL CENTRAL INDEX KEY: 0000885590 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 000000000 STATE OF INCORPORATION: A6 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 6-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14956 FILM NUMBER: 08774583 BUSINESS ADDRESS: STREET 1: 7150 MISSISSAUGA ROAD STREET 2: MISSISSAUGA CITY: ONTARIO STATE: A6 ZIP: 00000 BUSINESS PHONE: 905 286-3000 MAIL ADDRESS: STREET 1: 7150 MISSISSAUGA ROAD STREET 2: MISSISSAUGA CITY: ONTARIO STATE: A6 ZIP: 00000 6-K 1 a08-12050_46k.htm 6-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 6-K

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16 OF

THE SECURITIES EXCHANGE ACT OF 1934

 

April 24, 2008

 

Commission File Number 001-14956

 

BIOVAIL CORPORATION

(Translation of Registrant’s name into English)

 

7150 Mississauga Road, Mississauga, Ontario, CANADA, L5N 8M5

(Address of principal executive office and zip code)

 

Registrant’s telephone number, including area code: (905) 286-3000

 

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

 

Form 20-F x

 

Form 40-F o

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1).

 

Yes o

 

No x

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7).

 

Yes o

 

No x

 

Indicate by check mark whether by furnishing the information contained in this form the registrant is also hereby furnishing the information to the Commission pursuant to Rule 12g 3-2(b) under the Securities Exchange Act of 1934.

 

Yes o

 

No x

 

 



 

BIOVAIL CORPORATION

 

This Report of Foreign Private Issuer on Form 6-K is incorporated by reference into the registration statements on Form S-8 (Registration Nos. 333-92229 and 333-138697) of Biovail Corporation.

 

INDEX

 

Exhibit 99.1                                    News Release dated April 23, 2008 – Biovail Receives FDA Approval for AplenzinTM  (BVF-033)

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

 

Biovail Corporation

 

 

 

 

 

 

 

 

Date:

April 24, 2008

By:

/ s / Jennifer Tindale

 

 

 

Jennifer Tindale

 

 

 

Vice President &

 

 

 

  Associate General Counsel

 

2


EX-99.1 2 a08-12050_4ex99d1.htm EX-99.1

Exhibit 99.1

 

CONTACT: Nelson F. Isabel

Vice-President, Investor Relations and Corporate Communications

 (905) 286-3000

 

For Immediate Release:

 

BIOVAIL RECEIVES FDA APPROVAL FOR APLENZIN™ (BVF-033)

 

Toronto, Canada, April 23, 2008 – Biovail Corporation (NYSE, TSX: BVF) announced today that it has received Approval from the United States Food and Drug Administration (FDA) for its New Drug Application (NDA) for Aplenzin™ (formerly known as BVF-033), a once-daily formulation of bupropion hydrobromide developed by Biovail for the treatment of depression in adults.

 

Aplenzin™ is an alcohol-resistant formulation of a new bupropion salt and has been approved in 174mg, 348mg, and 522mg extended-release tablets. The 522mg dosage strength provides patients requiring the maximum allowable dose of bupropion the only single tablet, once-daily option.

 

Biovail remains in active partnership discussions for the commercialization rights for Aplenzin™ in the United States.

 

About Biovail Corporation

 

Biovail Corporation is a specialty pharmaceutical company, engaged in the formulation, clinical testing, registration, manufacture, and commercialization of pharmaceutical products utilizing advanced drug-delivery technologies. For more information about Biovail, visit the Company’s Web site at www.biovail.com.

 



 

For further information, please contact Nelson F. Isabel at 905-286-3000 or send inquiries to ir@biovail.com.

 


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