Guidelines

Ajanta Pharma has launched its generic of Concordia Pharmaceuticals’ Kapvay (clonidine hydrochloride) extended-release tablets. The Mumbai-based company’s launch of the product follows the Food and Drug Administration approving it on Tuesday.

The drug is indicated to treat attention deficit hyperactivity disorder as a monotherapy and as adjunctive treatment to stimulants. Ajanta’s generic will be available in 0.1-mg dosage strength.

The Food and Drug Administration has approved Glenmark Pharmaceuticals’ generic of Allergan’s Hailey Fe 1/20 norethindrone acetate, 1 mg, and ethinyl estradiol, 20 mcg) tablets.

The drug is indicated to prevent pregnancy. It had U.S. brand and generic sales of roughly $116.8 million, according to data from IQVIA for the 12 months ended September 2017.

Glenmark said that its portfolio currently consists of 129 products in the United States, with a further 58 applications pending FDA approval.
 

Canadian organization Public Health Ontario and the Institute for Clinical Evaluative Sciences have published new research underscoring the ability of the flu vaccine to reduce hospitalization risk in children. The study found that fully vaccinated children’s risk of flu-related hospitalization decrease 60% and that partially vaccinated children’s risk decreasing 39%.

A recent Morbidity and Mortality Weekly report from the Centers for Disease Control and Prevention showcases an increase in the number of pregnant women who opt to receive a tetanus toxoid, reduced diphtheria toxoid and acellular pertussis, or Tdap, vaccine.

Two countries with the world’s highest incidence of Type 1 diabetes are working together to develop a vaccine for the illness, noting that a recent model in mice prevented virus-induced diabetes. The researchers at Sweden’s Karolinska Instituet and Finland’s university of Tampere said that this presents a clinically relevant model for Type 1 diabetes in humans, and that it had no adverse effects on vaccinated animals. 

The Food and Drug Administration has approved Cipla’s generic of AstraZeneca's Pulmicort Respules (budesonide inhalation suspension). The drug is indicated as a maintenance treatment for asthma and as prophylactic therapy in children ages 12 months to 8 years. The Mumbai-based Cipla said the drug was available immediately for shipment.

Cipla’s generic will be available in dosage strengths of 0.25 mg/2 ml, 0.5 mg/2 ml and 1 mg/2ml. The product and its generics had U.S. sales of roughly $825 million for the 12 months ended September 2017, according to IQVIA data.

Cardinal Health has unveiled a big push to combat the opioid epidemic in the four Appalachian states that have been hit hardest by it. The Opioid Action plan is a pilot that officials at the Dublin, Ohio-based company said would bring front-line tools to first responders in Ohio, Kentucky, Tennessee and West Virginia, while increasing its investment in education.

Getting biosimilars to market remains an obstacle course for manufacturers and could result in higher prices for consumers and less profits for retailers.

Even as more approvals roll in and industry officials talk about how biosimilars will bring significant savings in the coming decade, there is a concern that regulatory and reimbursement hurdles could prevent the industry from realizing the full savings of the less-expensive alternative to biologics.