Feb 24, 2020
FDA approves first generic of ProAir HFA
Jan 07, 2020
Top 5 Generic Opportunities in Pharmaceuticals to Watch in 2019: Perspective for the Future
Dec 20, 2019
e5 Pharma Launches Generic Form of Diazoxide; Approved by FDA
Dec 02, 2019
Breckenridge Announces Final Approval of its ANDA for Rivastigmine Transdermal System (generic for Exelon® Patch)
Sep 30, 2019
LSNE Receives Approval To Manufacture Commercial Aseptic Generic Product At Its Recently Acquired Facility In León, Spain
Jun 18, 2019
Statement from Acting FDA Commissioner Ned Sharpless, M.D., on a new effort to improve transparency and predictability for generic drug applicants to help increase timely access to high-quality, lower cost generic drugs
May 08, 2019
Amerigen Announces U.S. FDA Approval For Generic Penicillamine 250 mg Capsules
Mar 07, 2019
CASI Pharmaceuticals Announces China National Medical Products Administration (NMPA) Approval Of CTA To Conduct Registration Trial For MARQIBO®
Jan 30, 2019
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency's efforts to enhance the utility of the Orange Book to foster drug competition
Jan 16, 2019
FDA approves first generic version of Sabril to help treat seizures in adults and pediatric patients with epilepsy
Oct 23, 2018
CASI Pharmaceuticals Acquires HBV ANDA from Laurus Labs Limited
Oct 09, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new efforts to advance the development of generic copies of complex drugs to improve patient access to medicines
Aug 08, 2018
FDA approves first generic drug under new pathway aimed at enhancing market competition for sole source drugs
May 17, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D., on new agency efforts to shine light on situations where drug makers may be pursuing gaming tactics to delay generic competition
May 03, 2018
Pharmaceutical Patent Litigation Increases Nearly 30 Percent in 2017: Lex Machina Releases Fourth Hatch-Waxman/ANDA Litigation Report
Apr 24, 2018
Remarks from FDA Commissioner Scott Gottlieb, M.D., as prepared for testimony before a U.S. Senate Committee on Appropriations on FDA's Fiscal Year 2019 budget
Mar 20, 2018
Amerigen Pharmaceuticals Limited today announced that its Abbreviated New Drug Application for cyclophosphamide capsules 25mg and 50mg has received final approval from the U.S. Food and Drug Administration
Jan 26, 2018
CASI Pharmaceuticals Acquires ANDA Portfolio From Sandoz Inc. (Sandoz)
Jan 16, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D. responding to report from GAO and updating on FDA's ongoing efforts to increase access to complex generic drugs
Jan 03, 2018
Statement from FDA Commissioner Scott Gottlieb, M.D. on new steps to facilitate efficient generic drug review to enhance competition, promote access and lower drug prices