CDC identifies risk of Zika virus transmission across three Florida counties
ATLANTA — The Centers for Disease Control and Prevention on Monday identified a potential risk of Zika virus transmission starting on June, 15, 2016, to present in Miami-Dade County, Fla., that also could affect risk for residents of Broward and Palm Beach counties.
CDC recently collaborated with the Florida Department of Health to conduct additional analysis of locally acquired Zika cases, including analysis of resident travel patterns between Miami-Dade, Broward and Palm Beach counties. This analysis has led to CDC identifying that since June 15, 2016, there has been a potential increased Zika risk for residents in Broward and Palm Beach counties because of local travel to areas of active transmission in Florida and challenges associated with defining sources of exposure.
This increased risk is particularly relevant for semen because of evidence regarding the persistence of Zika virus in this reproductive tissue.
This potential increased risk of Zika virus exposure associated with semen may be attributed to evidence confirming that Zika virus can persist in semen longer than in other body fluids and the ongoing concern about Zika virus infections that go undiagnosed because people have mild or no symptoms.
Blood donations throughout the United States are tested for Zika with laboratory testing, resulting in the removal of Zika virus positive collections in multiple states and Puerto Rico. Testing for tissue donors, including semen donors, is not currently available; however, tissue donors are asked travel history questions, and if they have traveled to or live in an area of active Zika virus transmission they would be determined ineligible under current FDA guidance.
CDC encourages women and their partners, in consultation with their healthcare providers, to consider this potential risk when trying to conceive. Additionally, healthcare providers should counsel their pregnant patients who might have been exposed to semen from men potentially infected with Zika virus about this risk. Zika virus infection during pregnancy can cause brain abnormalities, microcephaly and congenital Zika syndrome, a pattern of conditions in the baby that includes brain abnormalities, eye defects, hearing loss and limb defects.
In collaboration with the Florida Department of Health, CDC has issued guidance to prevent Zika transmission for residents and visitors to the tri-county area.
Lupin launches hydrocodone bitartrate generic
BALTIMORE — Lupin launched hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg in the United States.
Lupin’s hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg are the AA rated generic equivalent of Mikart’s hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg. It is indicated for the relief of moderate to moderately severe pain.
Hydrocodone bitartrate and acetaminophen tablets USP, 5 mg/300 mg, 7.5 mg/300 mg and 10 mg/300 mg had combined sales of $79.6 million.
Mayne Pharma acquires rights to fentanyl TDS
ADELAIDE, South Australia — Mayne Pharma acquired the rights to the fentanyl transdermal delivery system, 25 mcg/hr, 50 mcg/hr, 75 mcg/hr and 100 mcg/hr from Par Pharmaceutical, which allows the company to now market the product in the United States.
This product was developed by Corium, a specialty pharmaceutical company focused on the development and manufacture of transdermal and transmucosal delivery systems. Fentanyl TDS is a generic equivalent to Duragesic, indicated for the management of pain in opioid-tolerant patients, severe enough to require daily treatment.
Mayne Pharma has assumed Par’s manufacturing and supply agreement with Corium. “We are very pleased to have partnered with Corium on another complex, difficult-to-develop and manufacture product,” said Mayne Pharma’s CEO Scott Richards. “The U.S. transdermal patch market is valued at more than $3.3 billion and is a well-regarded advanced drug delivery system that can better control drug release and can also lead to improved patient convenience and compliance.”
According to IMS Health, the annual market sales for the fentanyl patch were approximately $560 million for the 12 months ending Dec. 31.
“Mayne Pharma’s first marketed patch was Clonidine, indicated for the treatment of hypertension and is one of Mayne Pharma’s top five generic products by sales,” said Richards. “Our alliance with Corium now includes two marketed and one pipeline product that is filed with the U.S. Food and Drug Administration and reinforces one of the key strategic benefits of the Teva Portfolio acquisition to access a pipeline of new product opportunities through leveraging relationships with active pharmaceutical ingredient suppliers and contract development and manufacturing companies.”