FDA’s new hep C approval: A step closer to a cure?
October 13th 2014FDA’s approval of ledipasvir 90 mg/sofosbuvir 400 mg (Harvoni, Gilead Sciences), the first once-daily single tablet regimen for the treatment of chronic hepatitis C genotype 1 infection in adults, may signal that industry is at the forefront of a cure for hepatitis C, according to one industry expert.
FDA approves first drug-coated balloon catheter
October 10th 2014FDA approved the Lutonix 035 Drug Coated Balloon (DCB) Catheter (Bard) for percutaneous transluminal angioplasty (PTA), after pre-dilatation, for the treatment of de novo or restenotic lesions up to 150 mm in length in native vascular disease of the superficial femoral or popliteal arteries with reference vessel diameters of 4 mm to 6 mm.
First long-term treatment for DME approved by FDA
September 30th 2014FDA has approved fluocinolone acetonide intravitreal implant (Iluvien, Alimera) 0.19 mg for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure (IOP). Iluvien was approved without any restriction requiring patients to have undergone, or be scheduled for, cataract surgery.
FDA approves subcutaneous injection for opioid-induced constipation in chronic non-cancer pain
September 30th 2014FDA approved methylnaltrexone bromide (Relistor, Salix Pharmaceuticals and Progenics Pharmaceuticals) subcutaneous injection, 12 mg/0.6 mL, for the treatment of opioid-induced constipation (OIC) in patients taking opioids for chronic non-cancer pain.
FDA approves Promacta for use in patients with serious blood disorder
August 28th 2014FDA has approved a new indication for the once-daily use of eltrombopag (Promacta, GlaxoSmithKline) in patients with severe aplastic anaemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).
FDA approves diclofenac for managing OA pain
August 25th 2014Zorvolex was the first FDA-approved low dose NSAID developed using proprietary SoluMatrix Fine Particle Technology. Zorvolex contains diclofenac as submicron particles that are approximately 20 times smaller than their original size. The reduction in particle size provides an increased surface area, leading to faster dissolution. By using this technology, the dose can be lowered without delaying absorbtion.
FDA approves oritavancin for skin infections
August 7th 2014FDA has approved oritavancin (Orbactiv, The Medicines Company) for injection for the treatment of adults with acute bacterial skin and skin structure infections (ABSSSIs) caused by susceptible designated Gram-positive bacteria including methicillin-resistant Staphylococcus aureus (MRSA).
FDA approves empagliflozin tablets for type 2 diabetes
August 5th 2014FDA approved empagliflozin (Jardiance, Boehringer Ingelheim Pharmaceuticals and Eli Lilly and Company) tablets as an adjunct to diet and exercise to improve glycemic control, or blood glucose levels, in adults with type 2 diabetes. Jardiance is not for people with type 1 diabetes or for people with diabetic ketoacidosis (increased ketones in the blood or urine).
FDA approves Striverdi Respimat to treat COPD
August 4th 2014FDA has approved olodaterol (Striverdi Respimat, Boehringer Ingelheim) Inhalation Spray 5 µg as a long-term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.
FDA approves hard-to-abuse opioid pain drug
July 31st 2014FDA approved oxycodone hydrochloride and naloxone hydrochloride extended-release tablets (Targiniq ER, Purdue Pharma), an extended-release/long-acting (ER/LA) opioid analgesic to treat pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.
FDA approves panitumumab plus FOLFOX for wild-type KRAS metastatic colorectal cancer
June 1st 2014FDA has approved panitumumab (Vectibix, Amgen) for use in combination with FOLFOX, an oxaliplatin-based chemotherapy regimen, as first-line treatment in patients with wild-type KRAS (exon 2) metastatic colorectal cancer (mCRC).
FDA approves clot-busting vorapaxar
May 9th 2014FDA approved vorapaxar (Zontivity, Merck Sharp & Dohme Corp., a subsidiary of Merck) tablets to reduce the risk of heart attack, stroke, cardiovascular death, and need for procedures to restore the blood flow to the heart in patients with a previous heart attack or blockages in the arteries to the legs.
First HPV test for primary cervical cancer screening approved by FDA
April 28th 2014FDA approved the first HPV DNA test for women aged 25 years and older that can be used alone to help a healthcare professional assess the need for a woman to undergo additional diagnostic testing for cervical cancer. The test also can offer information about the patient’s risk for developing cervical cancer in the future.