FDA gives tentative approval to Aurobindo’s Tivicay generic
SILVER SPRING, Md. — The Food and Drug Administration has granted its tentative approval to Aurobindo Pharma for its generic of Tivicay (dolutegravir or DTG), making it the first approval for a generic of the HIV treatment recommended by the World Health Organization and the Centers for Disease Control and Prevention.
“The approval of the generic version of DTG shows the commitment towards the larger cause of bringing affordable HIV drugs to millions of people,” Aurobindo managing director N. Govindarajan said. “This is a one-of-its-kind agreement between innovator and generic company where the generic version of the drug will be launched in around three years from the originator product. Further, we are also developing a fixed-dose combination of DTG.”
Because of a licensing with Tivicay maker ViiV Healthcare allowing the generic to launch in 92 licensed countries after getting regulatory approval and the Clinton Health Access Initiative, Aurobindo expects its product to launch in sub-Saharan Africa in late 2016.
“Dolutegravir is a critical new tool that will help us achieve the UNAIDS 90-90-90 goals and an AIDS-free generation,” Clinton Health Access Initiative EVP David Ripin said. “The WHO included Dolutegravir in its recommendations for first-line therapy in 2015, and we expect rapid growth in demand now that a cost-effective generic product is available. Dolutegravir, taken with other HIV treatments, has the potential to improve the lives of millions of patients.”
Impax launches generic Metadate CD
HAYWARD, Calif. — Impax Laboratories on Thursday announced the launch of its generic of Metadate CD (methylphenidate hydrochloride) extended-release capsules.
Impax’s generic will be available in 10-, 20-, 30-, 40-, 50- and 60-mg dosage strengths. The drug had U.S. sales of about $151 million for the 12 months ended July 2016, according to IMS Health data.
Allergan, Adamas announce new Namzaric dosage strengths availability
DUBLIN and EMERYVILLE, Calif. —Allergan and Adamas Pharmaceuticals on Thursday announced the availability of all four dosage strengths of its Namzaric (memantine and donepezil hydrochloride) extended-release capsules.
Namzaric is a fixed-dose combination of memantine and 10 mg donepezil hydrochloride indicated to treat moderate to severe Alzheimer’s disease in patients stabilized on 10 mg of donepezil hydrochloride. The Food and Drug Administration approved the drug in July.
“We are excited that with the new available dosage strengths patients with moderate to severe Alzheimer's disease, who are currently stabilized on Aricept, donepezil hydrochloride (10 mg) can now start combination therapy directly with NAMZARIC,” Allergan chief medical officer Dr. Gavin Corcoran said. Namzaric offers these patients the benefits of combining two products that each work differently to treat moderate to severe Alzheimer's disease, without increasing the number of pills a patient and their caregiver need to administer each day.”
Namzaric will be commercially available in 30-count bottles of 7-, 10-, 14-, 21- and 28-mg memantine/10-mg donepezil hydrochloride dosage strengths.
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