Mylan Launches Two New HIV Treatments
March 2, 2018 – Drug manufacturer Mylan has announced the launch of two new drug therapies for the treatment of HIV. The products are Symfi Lo™ (efavirenz/lamivudine/tenofovir disoproxil fumarate) tablets and Cimduo™ (lamivudine/tenofovir disoproxil fumarate) tablets.
Approved February 5, 2018, by the U.S. FDA, both Symfi Lo and Cimduo are indicated to treat HIV-1 in adults, as well as in children who weigh at least 35kg (77lbs). Combination tablets like Symfi Lo and Cimduo can ease the burden of treatment for patients with HIV, as typically more than one class of anti-HIV drug is used at a time. This multipronged approach helps to reduce the chance of the virus developing resistance to treatment. Combined tablets simplify dosing schedules, making it easier for patients to take their medication as prescribed.
Symfi Lo is a once-daily therapy that can be used alone. Also a once-daily therapy, Cimduo is indicated for use in conjunction with other antiretroviral drugs. Both drugs carry black box warnings, as discontinuing them could exacerbate hepatitis B (HBV) in patients who stop taking them and are co-infected with HIV and HBV.
Mylan is expected to launch Symfi soon, while Cimduo is not expected to launch until the second half of 2018. Pricing information is not yet available.
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.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. 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 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.