FDA approves Prevnar 13 in older adults
NEW YORK — The Food and Drug Administration has approved a Pfizer vaccine for Streptococcus pneumoniae in adults ages 50 years and older, the company said.
Pfizer announced the FDA approval of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) as a single-dose for adults.
"Pneumococcal disease, including pneumonia, in adults 50 years and older represents a significant personal and social health burden in the United States," Pfizer chairman and CEO Ian Read said. "The FDA approval of Prevnar 13 for these adults offers the potential to contribute to the health of millions of aging Americans."
FDA approves Mylan epilepsy drug
PITTSBURGH — The Food and Drug Administration has approved a drug for epilepsy made by Mylan, the drug maker said.
The FDA approved Mylan’s levetiracetam extended-release tablets in the 500-mg and 750-mg strengths.
The drug is a generic version of UCB’s Keppra XR, used to treat partial onset seizures in epilepsy patients ages 16 years and older.
Various versions of the drug had sales of about $162.8 million during the 12-month period ended in September, according to IMS Health.
FDA accepts application for Gilead HIV drug
FOSTER CITY, Calif. — The Food and Drug Administration has accepted a regulatory approval application from Gilead Sciences for a drug to treat HIV, the company said.
Gilead said the FDA planned to review the application for the Quad by Aug. 27.
The Quad combines four Gilead drugs — Truvada (emtricitabine and tenofovir disoproxil fumarate), cobicistat and elvitegravir — into one pill. The last drug was licensed from Japan Tobacco.