PHARMACY

FDA approves Iroko Pharmaceuticals NSAID

BY Alaric DeArment

PHILADELPHIA — The Food and Drug Administration has approved a pain drug made by Iroko Pharmaceuticals, Iroko said.

The drug maker announced the approval of Zorvolex (diclofenac) capsules for mild to moderate acute pain in adults. The drug is a non-steroidal anti-inflammatory drug, or NSAID, belonging to the same class as the common analgesic drug ibuprofen. Zorvolex was approved at dosage strengths 20% lower than currently available diclofenac products, the company said.

"The approval of Zorvolex is important news for patients and for physicians who need new options for effective pain relief and is a significant milestone for Iroko," Iroko president and CEO John Vavricka said. "This marks a major achievement toward our goal of applying new technology to existing NSAIDs in order to address unmet medical needs in analgesia."

 

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PHARMACY

FDA approves Opsumit for pulmonary arterial hypertension

BY Alaric DeArment

SILVER SPRING, Md. — The Food and Drug Administration has approved a new drug made by Actelion Pharmaceuticals for treating pulmonary arterial hypertension.

The agency announced the approval of Opsumit (macitentan) for adults with PAH, a chronic, progressive and debilitating disease caused by high blood pressure in the arteries that connect the heart to the lungs that can lead to death or the need for lung transplantation.

The FDA said the drug would carry a boxed warning, the highest warning possible, alerting patients and healthcare providers that Opsumit should not be used in pregnant women because it can harm a developing fetus. Women can only receive the drug through a risk evaluation and mitigation strategy program.

 

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FDA approves new injector pen for Merck KGaA fertility drug

BY Alaric DeArment

DARMSTADT, Germany — The Food and Drug Administration has approved a pre-filled injector pen made by EMD Serono for infertile women, the company said Friday.

The drug maker — the U.S. subsidiary of Germany’s Merck Serono, so-called to distinguish it from U.S.-based Merck & Co. — announced the approval of Gonal-f RFF Redi-ject (follitropin alfa), a disposable pre-filled injector pen intended for injection under the skin of a liquid formulation of Gonal-f RFF. The pens will be available in the United States in December.

"With a complete portfolio of gonadotropins, Merck Serono is continuously innovating to improve its administration devices in order to meet the needs of patients and healthcare professionals," Merck Serono global head of research and development Annalisa Jenkins said. "We have a strong legacy in fertility, and the approval of the Gonal-F RFF Redi-ject in the [United States] further demonstrates our commitment to building our leadership position in this important therapeutic area as we look to the future."

Merck Serono, itself part of Merck KGaA, was originally the parent company of Merck & Co., but the two were split during World War I as part of a broader seizure of German assets in the United States. 

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