January 2017

Lipocine Inc.  announced receipt of additional guidance from the U.S. Food and Drug Administration ("FDA") on the LPCN 1107 pivotal Phase 3 clinical study design.  LPCN 1107, a novel oral hydroxyprogesterone caproate ("HPC") product candidate that has been granted orphan drug designation by the FDA, is in development for the proposed indication of reducing the risk of preterm birth ("PTB") in women with singleton pregnancy who have a history of singleton spontaneous PTB. Prevention of PTB is a significant unmet need as ~11.7% of all U.S. pregnancies result in PTB (delivery less than 37 weeks), a leading cause of neonatal mortality and morbidity

Egalet Corporation announced that the U.S. Food and Drug Administration (FDA) has approved ARYMO™ ER (morphine sulfate) extended-release (ER) tablets C-II for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Ajanta Pharma Limited, a specialty pharmaceutical formulation company, has received US FDA final approval for duloxetine hydrochloride delayed release capsules.

AcelRx Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of moderate-to-severe acute pain, has recently announced that the US Food and Drug Administration (FDA) has conditionally accepted the brand name, Dsuvia (sufentanil sublingual tablet, 30 mcg), for the company's investigational product candidate, ARX-04. In addition, AcelRx has applied to the US Patent and Trademark Office to obtain federal registration of the Dsuvia mark.