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FDA accepts NDA for Agile’s contraceptive patch

BY Allison Cerra

PRINCETON, N.J. — The Food and Drug Administration has accepted a new drug application for a low-dose, once-weekly contraceptive patch from Agile Therapeutics, the drug maker said.

Agile said it expects the FDA to respond to its NDA for AG200-15 — a combination hormonal contraceptive patch, which in clinical studies has been shown to deliver a low dose of ethinyl estradiol, as well as a dose of levonorgestrel that is consistent with that of low-dose oral contraceptives — by first quarter 2013. The patch is applied once weekly for three weeks, followed by a fourth patch-free week. The patch may be applied to the abdomen, buttocks or upper torso, is soft and flexible with a cloth-like, silky feel and designed to provide adhesion, comfort and appearance, Agile said.

"We are very pleased with the FDA’s acceptance of our AG200-15 NDA filing," Agile president and CEO Al Altomari said. "This is an important milestone for our company and reflects the unwavering commitment of the entire Agile team to advance a new contraceptive option for women. We will work closely with the FDA to bring AG200-15 to market as soon as possible."


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Amgen completes Kai acquisition

BY Allison Cerra

THOUSAND OAKS, Calif. — Amgen has completed its acquisition of Kai Pharmaceuticals, a privately held company based in South San Francisco, Calif.

The deal, first announced in April, is valued at $315 million. The deal also includes the acquisition of KAI-4169, an experimental drug Kai is developing for secondary hyperparathyroidism in patients with chronic kidney disease who are on dialysis. KAI previously reported compelling mid-stage clinical results for KAI-4169 in this indication.


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Lilly gains U.S. pediatric exclusivity for Cymbalta

BY Allison Cerra

INDIANAPOLIS — Eli Lilly announced that it has met Food and Drug Administration requirements for pediatric exclusivity for its antidepressant medication.

Based on this decision by the FDA, Lilly has gained an additional six months of U.S. market exclusivity for Cymbalta (duloxetine hydrochloride), which now will expire in December 2013.

Lilly noted, however, that the approval of pediatric exclusivity does not mean that the serotonin and norepinephrine reuptake inhibitor is approved for use in pediatric patients. Cymbalta only is approved for use in adults ages 18 years and older. Based on study results, Lilly will not be seeking a pediatric indication for Cymbalta, the drug maker said.


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