Actavis and Sagent Pharmaceuticals have agreed to develop and market a group of injectable drugs in the United States, Actavis announced.
Under the agreement, Actavis will develop the drugs, seek Food and Drug Administration approval for them and supply them, while Sagent will market them. Financial terms of the deal were not disclosed.
“Actavis’ impressive injectable pipeline, substantial development and supply capabilities and excellent record of execution make Actavis an outstanding partner for Sagent,” Sagent CEO and board chairman Jeffrey Yordon said. “This collaboration complements Sagent’s strategy by quickly adding products to our marketed portfolio, and we look forward to working with Actavis to expand our collective portfolio.”
The Food and Drug Administration has approved a new oral contraceptive made by Bayer HealthCare Pharmaceuticals, the agency announced.
The FDA approved Bayer’s Natazia (estradiol valerate and dienogest), which combines an estrogen and a progestin into what the agency called the first four-phasic contraceptive marketed in the United States. “Four-phasic” means that the doses of the two hormones vary four times throughout each treatment cycle.
“Nearly 12 million women in the United States and more than 100 million women worldwide currently use oral contraceptives,” FDA Division of Reproductive and Urologic Products director Scott Monroe said. “The approval of Natazia provides another option for women who choose to use an oral contraceptive as their method of contraception.”
The Food and Drug Administration has declined to approve a biotech drug for organ transplant patients made by Bristol-Myers Squibb, Bristol said.
The FDA issued a complete response letter for Bristol’s September 2009 regulatory approval application for belatacept, designed to prevent rejection of transplanted kidneys. The agency issues a complete response letter when it has finished reviewing an application, but questions remain that preclude final approval. Specifically, the letter requested from Bristol three-year data from a late-stage clinical trial to further evaluate the drug’s long-term effect.
“Bristol-Myers Squibb is committed to belatacept as a potential new therapeutic option for kidney transplant patients,” Bristol SVP global development and medical affairs Brian Daniels said. “We will continue to work closely with the FDA to address their questions.”
A Forest Labs drug used to treat mild to moderate hypertension “significantly” reduced blood pressure in Hispanic patients when used alone, according to post-marketing study data recently presented at the American Society of Hypertension’s annual scientific meeting.
In a 277-patient phase-4 study, the drug Bystolic (nebivolol) reduced sitting systolic and diastolic blood pressure. The study included 113 Hispanic women and 164 men. According to Forest, Hispanics have higher rates of diabetes and obesity than Caucasians, and a study by the National Center for Health Statistics showed that more than 20% of adult Hispanics have hypertension.
“Bystolic is one of the only anti-hypertensives to have been prospectively evaluated for efficacy and safety in Hispanic patients, which is important given the lack of awareness, poor control and risk factors in this growing population,” University of Texas Southwestern Medical Center clinical assistant professor and study investigator Henry Punzi said. “These positive results show Bystolic is an effective treatment option with good tolerability for Hispanic patients with hypertension and add to the growing body of evidence in support of the clinical profile of the drug.”
Following last year’s efforts to support bipolar depression awareness and education, AstraZeneca is relaunching The Bipolar Journey: Living With Bipolar Depression interactive exhibit in a second tour designed for patients and caregivers.
The national 10-city tour kicked off at the Depression and Bipolar Support Alliance 2010 National Conference on April 29 in Itasca, Ill. This year, the exhibit will be extended to patients and caregivers in additional cities across America through a scaled, tabletop version of the exhibit that incorporates all of its assets in a smaller, compact version.
In its second run, The Bipolar Journey will continue to feature much of the same imagery, multimedia activities and interactive tools that helped patients last year connect with experts and other patients and caregivers who have dealt with the impact of bipolar depression in their own lives. This year, the exhibit also includes a podcast listening station, a short video, several educational materials people can take home and the opportunity to explore
Sandoz has launched a generic antibiotic for pneumonia and acute sinus infections, the generics arm of Swiss drug maker Novartis said.
Sandoz said it launched amoxicillin and clavulanate potassium extended-release tablets, a generic version of GlaxoSmithKline’s Augmentin XR, in the 1,000-mg/62.5-mg strengths. The tablets are used to treat community-acquired pneumonia and acute bacterial sinusitis. Sandoz said it was the first company to file a regulatory approval application for the drug with the Food and Drug Administration, entitling it to six months’ market exclusivity.
Augmentin XR had sales of $53 million during the 12-month period that ended in January, according to IMS Health.