FDA gives green light to ANDA for chewable diabetes tablet
October 8th 2012FDA has approved Boston Therapeutic’s petition to file an Abbreviated New Drug Application (ANDA) for a new, chewable tablet formulation of the diabetes drug metformin hydrochloride. The company plans to market the new formulation under the name Pazamet.
FDA Actions in Brief September 2012
October 1st 2012Recent FDA Approvals (through August 2012) related to (Innocutise, Genzyme, Sanofi, Pfizer, Amgen, Astellas Pharma US, Medivation, Gilead Sciences, Ironwood Pharmaceuticals, Forest, Reckitt Benckiser, Boehringer Ingelheim, Eli Lilly, Sicor Biotech UAB, Teva Corporation, Novartis)
Prepopik (Sodium picosulfate and magnesium oxide and anhydrous citric acid for oral solution)
October 1st 2012New molecular entity: FDA approved the combination of sodium picosulfate (a stimulant laxative) and magnesium oxide and anhydrous citric acid (which form magnesium citrate, an osmotic laxative) (Prepopik, Ferring Pharmaceuticals) for cleansing of the colon as a preparation for colonoscopy in adults.
FDA approves Humira to treat ulcerative colitis
October 1st 2012FDA has approved adalimumab (Humira, Abbott) for inducing and sustaining clinical remission in adult patients with moderately to severely active ulcerative colitis (UC) when certain other medicines have not worked well enough. Combined with its approval to treat moderate-to-severe Crohn's disease, adalimumab is now approved for the treatment of the 2 primary diseases that comprise inflammatory bowel disease.
Belviq (Lorcaserin): A 5-HT2C receptor agonist indicated to treat certain overweight or obese adults
September 1st 2012New molecular entity: FDA approved Lorcaserin (Belviq, Arena Pharmaceuticals GMBH), as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index deemed obese and the presence of at least 1 weight-related comorbid condition.
Metastatic colorectal cancer treatment is approved
August 6th 2012FDA has approved ziv-aflibercept (Zaltrap, Sanofi and Regeneron Pharmaceuticals) injection for intravenous infusion, in combination with 5-fluorouracil, leucovorin, irinotecan (FOLFIRI), for patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatin-containing regimen.
Prednisone delayed-release tablets approved for rheumatology indications
July 27th 2012FDA has approved prednisone (Rayos, Horizon Pharma) delayed-release tablets (1 mg, 2 mg, and 5 mg) to treat a broad range of diseases including rheumatoid arthritis, polymyalgia rheumatica, psoriatic arthritis, ankylosing spondylitis, asthma, and chronic obstructive pulmonary disease.
FDA approves aclidinium bromide inhalation powder to treat COPD
July 24th 2012FDA has approved aclidinium bromide inhalation powder (Tudorza Pressair, Forest) for the long-term maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.
FDA approves carfilzomib for some patients with multiple myeloma
July 20th 2012FDA has approved carfilzomib (Kyprolis, Onyx Pharmaceuticals) to treat patients with multiple myeloma who have received at least 2 prior therapies, including treatment with bortezomib (Velcade, Takeda) and an immunomodulatory therapy.
FDA approves first generic Lexapro to treat depression, anxiety disorder
March 14th 2012Teva/IVAX Pharmaceuticals gained FDA approval for the first generic version of Lexapro (Forest) to treat both depression and generalized anxiety disorder in adults. The company will have 180 days to exclusively sell the product.
First medication approved by FDA for patients with endogenous Cushing's syndrome
February 21st 2012FDA has approved the first medication therapy, mifepristone (Korlym, Corcept Therapeutics), for endogenous Cushing's syndrome, a condition that, left untreated, has a mortality rate of 50% after 5 years.
FDA approves tablets for adult patients with type 2 diabetes
February 6th 2012FDA has approved (linagliptin/metformin hydrochloride (Jentadueto, Boehringer Ingelheim and Eli Lilly) tablets, which combine the dipeptidyl peptidase-4 (DPP-4) inhibitor, linagliptin, and metformin. Jentadueto provides a new, single-tablet treatment option, taken twice-daily, for patients who need to control their blood sugar.
FDA approves update to Gleevec label, extending treatment to certain GIST patients
February 6th 2012Following a priority review, FDA has approved an update to imatinib mesylate (Gleevec, Novartis) 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.
FDA approves extended-release tablets for type 2 diabetes
February 3rd 2012FDA approved sitagliptin and metformin hydrochloride (HCl) extended-release (Janumet XR, Merck) tablets, a new treatment for type 2 diabetes that combines sitagliptin, which is the active component of Januvia (sitagliptin), with extended-release metformin.
FDA approves ivacaftor to treat rare form of cystic fibrosis
February 1st 2012FDA approved ivacaftor (Kalydeco, Vertex Pharmaceuticals) for the treatment of a rare form of cystic fibrosis in patients aged 6 years and older who have the specific G551D mutation in the Cystic Fibrosis Transmembrane Regulator gene.