Feb 3 | News
WHITEHOUSE STATION, N.J. (AP) — Merck said Thursday it received U.S. approval for an extended-release version of its diabetes drug Janumet designed to be taken once a day, instead of twice a day.
|
Feb 2 | News
Mylan Inc. today announced that its subsidiary Mylan Laboratories Limited (formerly Matrix Laboratories Limited) has received tentative approval from the FDA for its Abbreviated New Drug Application (ANDA) for Atorvastatin Calcium Tablets, 10 mg (base), 20 mg (base), 40 mg (base) and 80 mg (base).
|
Feb 1 | News
Novartis announced today that following a priority review, the FDA has approved an update to the Gleevec (imatinib mesylate) tablets label to recommend 36 months of treatment after surgery for adult patients with KIT (CD117)-positive gastrointestinal stromal tumors (GIST) who met the risk of recurrence inclusion criteria of the pivotal trial.
|
Jan 24 | News
Takeda on Monday announced that the FDA approved a label update for Velcade (bortezomib) to include subcutaneous administration of the drug in all approved indications.
|
Jan 19 | News
Aptalis Pharma, a global specialty pharmaceutical company focused on gastrointestinal diseases and cystic fibrosis, today announced that the FDA has approved a New Drug Application (NDA) for Gilead Sciences, Inc.'s Viread (tenofovir disoproxil fumarate) oral powder in combination with other antiretroviral agents for the treatment of HIV-1 infection in pediatric patients ages 2-5.
|
Jan 18 | News
Novartis said today that it received Chinese regulatory approval for its eye drug Lucentis, and it is launching the diabetes treatment Galvus in China.
|
Jan 5 | News
INSYS Therapeutics has announced FDA approval of its branded breakthrough cancer pain medication, SUBSYS fentanyl sublingual spray.
|
Dec 19 2011 | News
Mylan Inc. has announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the FDA for its Abbreviated New Drug Application (ANDA) for Metoprolol Succinate Extended-release (ER) Tablets USP, 25 mg, 50 mg, 100 mg, and 200 mg.
|
Dec 1 2011 | News
Teva announced Thursday that U.S. regulators granted tentative approval to its generic version of Pfizer’s Lipitor (atorvastatin).
|
Nov 30 2011 | News
Watson Pharmaceuticals reported Tuesday that U.S. regulators cleared the company's oral contraceptive product Vestura, which is a generic version of Bayer's Yaz (drospirenone/ethinyl estradiol).
|