Posted from: Friday, November 10, 2017 - 06:23 PM - Present

Generic Launched for Ziagen

August 17, 2017 – Camber Pharmaceuticals has launched its generic to ViiV Healthcare’s Ziagen® (abacavir) oral solution, indicated to treat HIV when used in combination with other antiretroviral drugs. A nucleoside reverse transcriptase inhibitor (NRTI), abacavir oral solution is approved for use in children three months of age and up, as well as for older patients who may have difficulty swallowing medication in tablet form. Recommended dosing for pediatric patients is based on weight. For adults, the recommended dosing is 600mg per day, either taken as a single dose or split into two doses. For patients who have been diagnosed with hepatic impairment, recommended dosing is 200mg twice daily. All abacavir products carry a black box warning cautioning patients of the risk of severe and potentially fatal hypersensitivity reactions, lactic acidosis, and hepatomegaly with steatosis.

Brand name Ziagen oral solution sales for 2016 were estimated at $2 million. Camber’s generic received its U.S. FDA approval in September of 2016, and is available in a 20mg/mL bottle containing 240 mL of oral solution.

 

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 U.S. mail or by fax.

Actual drug patent expiration dates and 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.

 

 

Last Updated Monday, November 12, 2018 - 12:43 PM.