Orbactiv Approved For Acute Skin Infections
August 6, 2014 – The Food and Drug Administration (FDA) approved Orbactiv (oritavancin), manufactured by The Medicines Co. Orbactiv is a single dose treatment used for bacterial skin infections and is the third treatment approved for the same condition this year.
New therapies are continuously needed to help fight bacterial infections as patients build resistance to older therapies. These new medications are used to treat acute bacterial skin and skin structure infections (ABSSI) caused by strain of bacterial called Gram positive. Gram positive involves deep tissue and are associated with underlying conditions such as diabetes.
Orbactiv provides the full course of treatment through a single 1200mg dose, unlike available alternatives that offer a duration of treatment that can last up to 10 days. This new antibiotic, Orbactiv, is anticipated to be available in the market during the fourth quarter of 2014.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.