GlobeNewswire: Lipocine Inc. Contains the last 10 of 100 releaseshttp://www.globenewswire.com/External?Length=42024-03-19T10:22:06ZGlobeNewswirehttp://www.globenewswire.com/External?Length=4newsdesk@globenewswire.com (NewsDesk)https://www.globenewswire.com/news-release/2017/11/17/1194832/0/en/U-S-FDA-Extends-Review-for-TLANDO-Advisory-Committee-Meeting-Date-of-January-10-2018-Remains-Unchanged.html?f=22&fvtc=4&fvtv=20599U.S. FDA Extends Review for TLANDO™; Advisory Committee Meeting Date of January 10, 2018 Remains Unchanged2017-11-17T13:00:00Z<![CDATA[SALT LAKE CITY, Nov. 17, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has extended the review period for the New Drug Application (“NDA”) for TLANDO, the Company’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has assigned a new Prescription Drug User Fee Act (“PDUFA”) goal date of May 8, 2018.]]>https://www.globenewswire.com/news-release/2017/11/08/1177760/0/en/Lipocine-Announces-Financial-and-Operational-Results-for-the-Third-Quarter-and-Nine-Months-Ended-September-30-2017.html?f=22&fvtc=4&fvtv=20599Lipocine Announces Financial and Operational Results for the Third Quarter and Nine Months Ended September 30, 20172017-11-08T13:00:00Z<![CDATA[SALT LAKE CITY, Nov. 08, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the three and nine months ended September 30, 2017.]]>https://www.globenewswire.com/news-release/2017/10/18/1149166/0/en/FDA-Advisory-Committee-Scheduled-to-Review-TLANDO-on-January-10-2018.html?f=22&fvtc=4&fvtv=20599FDA Advisory Committee Scheduled to Review TLANDO™ on January 10, 20182017-10-18T12:00:00Z<![CDATA[SALT LAKE CITY, Oct. 18, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced the U.S. Food and Drug Administration (“FDA”) has scheduled the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) meeting on January 10, 2018 to discuss the New Drug Application (“NDA”) for TLANDO, the Company’s oral testosterone product candidate for the proposed indication of testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has previously set February 8, 2018 as the Prescription Drug User Fee Act ("PDUFA") goal date.]]>https://www.globenewswire.com/news-release/2017/09/21/1125842/0/en/Lipocine-Announces-Motions-Decision-by-USPTO-in-Interference-Against-Clarus.html?f=22&fvtc=4&fvtv=20599Lipocine Announces Motions Decision by USPTO in Interference Against Clarus2017-09-21T12:00:00Z<![CDATA[SALT LAKE CITY , Sept. 21, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the Patent Trial and Appeal Board (“PTAB”) of the United States Patent and Trademark Office (“USPTO”) issued a Motions Decision based on each party’s motions in the interference case, Patent Interference No. 106,045, between Clarus Therapeutics, Inc. (“Clarus”) U.S. Patent No. 8,828,428 (the “Clarus ‘428 Patent”), and Lipocine Inc. (“Lipocine”), U.S. Patent Application No. 14/713,692 (the “Lipocine ‘692 Application”).]]>https://www.globenewswire.com/news-release/2017/09/20/1125173/0/en/Lipocine-Announces-FDA-Advisory-Committee-Meeting-for-TLANDO.html?f=22&fvtc=4&fvtv=20599Lipocine Announces FDA Advisory Committee Meeting for TLANDO™2017-09-20T12:00:00Z<![CDATA[SALT LAKE CITY, Sept. 20, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the Bone, Reproductive and Urologic Drugs Advisory Committee (“BRUDAC”) of the U.S. Food and Drug Administration (“FDA”) plans to discuss the New Drug Application (“NDA”) submitted by the Company for TLANDO, its oral testosterone product candidate for the proposed indication of testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The advisory committee meeting date has not been finalized but will occur prior to the Prescription Drug User Fee Act ("PDUFA") goal date of February 8, 2018.]]>https://www.globenewswire.com/news-release/2017/09/19/1124856/0/en/Lipocine-to-Present-at-the-Ladenburg-Thalmann-2017-Healthcare-Conference.html?f=22&fvtc=4&fvtv=20599Lipocine to Present at the Ladenburg Thalmann 2017 Healthcare Conference2017-09-19T19:01:53Z<![CDATA[SALT LAKE CITY, Sept. 19, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, announced today that Dr. Mahesh Patel, Chairman, President and CEO, will provide a corporate overview at the Ladenburg Thalmann 2017 Healthcare Conference, being held September 26, 2017 at the Sofitel Hotel, in New York City.]]>https://www.globenewswire.com/news-release/2017/09/05/1107631/0/en/Lipocine-to-Present-at-the-Rodman-Renshaw-19th-Annual-Global-Investment-Conference.html?f=22&fvtc=4&fvtv=20599Lipocine to Present at the Rodman & Renshaw 19th Annual Global Investment Conference2017-09-05T12:00:00Z<![CDATA[SALT LAKE CITY, Sept. 05, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, announced today that Dr. Mahesh Patel, Chairman, President and CEO, will provide a corporate overview at the Rodman & Renshaw 19th Annual Global Investment Conference, being held September 11-13, 2017 at the Lotte New York Palace Hotel, in New York City.]]>https://www.globenewswire.com/news-release/2017/08/14/1084278/0/en/Lipocine-Announces-FDA-Acknowledgement-of-TLANDO-LPCN-1021-NDA-Resubmission-PDUFA-Goal-Date-February-8-2018.html?f=22&fvtc=4&fvtv=20599Lipocine Announces FDA Acknowledgement of TLANDO™ (“LPCN 1021”) NDA Resubmission; PDUFA Goal Date, February 8, 20182017-08-14T12:00:00Z<![CDATA[SALT LAKE CITY, Aug. 14, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food & Drug Administration (“FDA”) has acknowledged receipt of the Company’s New Drug Application (“NDA”) resubmission for TLANDO, its oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism. The FDA has deemed the resubmission a complete response to its June 2016 Complete Response Letter (“CRL”) that requested additional information related to the dosing algorithm for the proposed label. The FDA has assigned a new Prescription Drug User Fee Act (“PDUFA”) goal date of February 8, 2018. The TLANDO NDA is based on the results of the Dosing Validation (“DV”) study. The DV study confirmed the efficacy of TLANDO with a fixed dose regimen without need for dose adjustment. TLANDO was well tolerated upon 52week exposure with no reports of drug related Serious Adverse Events (“SAEs”).]]>https://www.globenewswire.com/news-release/2017/08/09/1082507/0/en/Lipocine-Resubmits-NDA-for-Its-Oral-Testosterone-Product-Candidate-LPCN-1021-for-Treatment-of-Hypogonadism.html?f=22&fvtc=4&fvtv=20599Lipocine Resubmits NDA for Its Oral Testosterone Product Candidate, LPCN 1021, for Treatment of Hypogonadism2017-08-09T12:00:00Z<![CDATA[SALT LAKE CITY, Aug. 09, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced the resubmission of a New Drug Application (“NDA”) for LPCN 1021, its oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency of endogenous testosterone, also known as hypogonadism.]]>https://www.globenewswire.com/news-release/2017/08/07/1081029/0/en/Lipocine-Announces-Financial-and-Operational-Results-for-the-Second-Quarter-and-Six-Months-Ended-June-30-2017.html?f=22&fvtc=4&fvtv=20599Lipocine Announces Financial and Operational Results for the Second Quarter and Six Months Ended June 30, 20172017-08-07T12:00:00Z<![CDATA[SALT LAKE CITY, Aug. 07, 2017 (GLOBE NEWSWIRE) -- Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced financial results for the three and six months ended June 30, 2017.]]>