Archived FDA Events

12/17/14 - POZEN Inc. (NASDAQ: POZN), a pharmaceutical company committed to transforming medicine that transforms lives, announced today that their investigational drug candidates YOSPRALA™ 81/40 and 325/40 (aspirin / omeprazole delayed release tablets) have received a second complete response letter (CRL) from the U.S. Food and Drug Administration (FDA). A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form.

07/16/14 - POZEN Inc. (Nasdaq: POZN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review, the resubmission of the New Drug Application (NDA) for PA8140/PA32540. The FDA also indicated the NDA would be treated as a Class 2 resubmission; therefore, the new user fee goal date is December 30, 2014. Issues raised during an audit of the manufacturing facility producing an active ingredient used in the manufacture of the products were the only deficiencies noted in the Complete Response Letter (CRL) POZEN received on April 25, 2014. If such inspection deficiencies are not satisfactorily addressed by the new user fee goal date, the FDA could issue another CRL. POZEN has agreed substantively to FDA's most recent draft product labeling.

12/19/14 - FDA approved ZERBAXA for the treatment of adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) caused by designated susceptible Gram-negative bacteria.

06/19/14 - Cubist Pharmaceuticals, Inc. (NASDAQ: CBST) announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's New Drug Application (NDA) for its investigational antibiotic ceftolozane/tazobactam with Priority Review. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of December 21, 2014. Cubist is seeking FDA approval of ceftolozane/tazobactam for the treatment of complicated urinary tract Infections and complicated intra-abdominal infections.

12/19/14 - The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE: ABBV) VIEKIRA PAK, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

06/16/214 - AbbVie (NYSE: ABBV) announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. The NDA was submitted on April 21, 2014 and is supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy. NOTE: With Enanta Pharma (NASDAQ: ENTA).

12/19/14 - The U.S. Food and Drug Administration (FDA) has approved AbbVie's (NYSE: ABBV) VIEKIRA PAK�, an all-oral, interferon-free treatment, with or without ribavirin (RBV), for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis. VIEKIRA PAK is the only FDA-approved regimen that contains three distinct mechanisms of action - NS5A inhibitor, NS3/4A protease inhibitor and a non-nucleoside NS5B polymerase inhibitor - that work together to attack the virus at three separate stages of the disease lifecycle to inhibit it from reproducing.

06/16/214 - AbbVie (NYSE: ABBV) announced today that the New Drug Application (NDA) for its investigational, all-oral, interferon-free regimen for the treatment of adult patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection has been accepted by the U.S. Food and Drug Administration (FDA) and has been granted priority review. The NDA was submitted on April 21, 2014 and is supported by data from a large clinical program including six Phase III studies of more than 2,300 GT1 patients in over 25 countries. The regimen was granted a Breakthrough Therapy designation by the FDA in May 2013, a status given to investigational treatments for serious or life-threatening conditions with preliminary clinical evidence demonstrating substantial improvement on at least one clinically significant endpoint compared to available therapy. NOTE: With AbbVie (NYSE: ABBV).

12/22/14 - BioCryst Pharma (NASDAQ: BCRX) announced that the U.S. Food and Drug Administration (FDA) has approved RAPIVAB (peramivir injection), an intravenous (i.v.) neuraminidase inhibitor for the treatment of acute uncomplicated influenza in patients 18 years and older who have been symptomatic for no more than two days.

02/25/14 - BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous (i.v.) peramivir that was submitted to the FDA in December 2013. The FDA assigned the NDA a standard review time, resulting in a PDUFA (Prescription Drug User Fee Act) action date of December 23, 2014. The FDA has informed BioCryst that at this time, it does not plan to hold an Advisory Committee review of the NDA.