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Biodelivery Sciences Announces Fda Approval Of Change In Bunavail

The following excerpt is from the company's SEC filing.

Product Specification Allowing for Immediate Release of Product

New supply of BUNAVAIL expected to be in pharmacies within 48 hours

RALEIGH, N.C., October 15, 2015

- BioDelivery Sciences International, Inc. (NASDAQ: BDSI) announced that the U.S. Food and Drug Administration (FDA) has approved the companys Supplemental New Drug Application (sNDA) for a manufacturing specification change for BUNAVAIL

(buprenorphine and naloxone) buccal film (CIII).

The approval allows for the immediate release of BUNAVAIL inventory to wholesalers. BDSI will be shipping product to wholesalers this morning which should make product available in pharmacies as early as Friday.

The newly released product supplies are expected to satisfy current and anticipated demand, which has increased following the October 1 initiation of a contract providing exclusive, preferred formulary status for BUNAVAIL for Medicaid patients in the state of Tennessee.

All of us at BDSI want to thank the Division of Anesthesia, Analgesia and Addiction Products at FDA for working with us in an expeditious and collaborative fashion to help allow patients benefiting from BUNAVAIL treatment to maintain uninterrupted availability, said Dr. Mark A. Sirgo, President and Chief Executive Officer. We also want to thank all of the patients, physicians and other health providers, including pharmacists, for their patience and support during this period of inconvenience.

About BUNAVAIL

INDICATION

BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) is a prescription medicine indicated for the maintenance treatment of opioid dependence. BUNAVAIL should be used as part of a complete treatment plan to include counseling and psychosocial support.

Prescription use of this product is limited under the Drug Addiction Treatment Act (DATA).

IMPORTANT SAFETY INFORMATION

Keep BUNAVAIL (buprenorphine and naloxone) Buccal Film (CIII) out of the sight and reach of children. Ingestion of BUNAVAIL by a child may cause severe breathing problems and death. If a child takes BUNAVAIL, get emergency help right away.

Do not take BUNAVAIL if you are allergic to buprenorphine or naloxone, as serious negative effects including anaphylactic shock, have been reported.

Do not take BUNAVAIL before the effects of other opioids (e.g., heroin, methadone, oxycodone, morphine) have lessened as you may experience withdrawal symptoms.

Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how BUNAVAIL affects you.

BUNAVAIL contains buprenorphine, an opioid that can cause physical dependence. Your doctor can tell you more about the difference between physical dependence and drug addiction. Do not stop taking BUNAVAIL without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to this medicine.

Do not switch from BUNAVAIL to other...


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