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As Of Filer Filing For·On·As Docs:Size Issuer Agent 6/01/06 Viropharma Inc 8-K:7,9 5/31/06 3:240K RR Donnelley/FA |
Document/Exhibit Description Pages Size 1: 8-K Viropharma Corporation - Form 8-K HTML 17K 2: EX-99.1 Supplement to Petition for Stay of Action HTML 148K 3: EX-99.2 Press Release HTML 13K
| ViroPharma Corporation - Form 8-K |
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d)
OF THE SECURITIES EXCHANGE ACT OF 1934
Date of Report (Date of Earliest Event Reported): May 31, 2006
VIROPHARMA INCORPORATED
(Exact Name of Registrant as Specified in its Charter)
| DELAWARE | 0-021699 | 23-2789550 | ||
| (State or Other Jurisdiction of Incorporation or Organization) |
(Commission File Number) | (I.R.S. Employer Identification Number) |
397 EAGLEVIEW BOULEVARD, EXTON, PENNSYLVANIA 19341
(Address of Principal Executive Offices including Zip Code)
(610) 458-7300
(Registrant’s Telephone Number, Including Area Code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
| Item 7.01 | Regulation FD Disclosure |
On May 31, 2006, ViroPharma Incorporated filed a supplement to its Petition for Stay of Action with the U.S. Food and Drug Administration (FDA) regarding the bioequivalence requirements for abbreviated new drug applications that seek to copy Vancocin. The document sets forth legal arguments in support of ViroPharma’s strong belief that the decision of the FDA’s Office of Generic Drugs to lower the bioequivalence standards for generic copies of Vancocin violated numerous federal statutes and FDA’s own regulations with the result that the new standard cannot, as a matter of law, be used in the review or approval of applications for generic versions of Vancocin. A copy of the supplement to the Petition for Stay of Action and a press release announcing the filing are set forth as Exhibit 99.1 and 99.2 attached hereto.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| 99.1 | Supplement to Petition for Stay of Action. | |
| 99.2 | Press Release dated May 31, 2006 regarding supplement to Petition for Stay of Action. | |
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 hereunto duly authorized.
| VIROPHARMA INCORPORATED | ||||||||
| Date: June 1, 2006 |
By: |
/s/ Thomas F. Doyle | ||||||
| Vice President, General Counsel and Secretary | ||||||||
| Exhibit No. | Description | |
| EX-99.1 | Supplement to Petition for Stay of Action. | |
| EX-99.2 | Press Release dated May 31, 2006 regarding supplement to a Petition for Stay of Action. | |
| This ‘8-K’ Filing | Date | Other Filings | ||
|---|---|---|---|---|
 | ||||
| Filed on: | 6/1/06 | None on these Dates | ||
| For Period End: | 5/31/06 | |||
| List all Filings | ||||