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FDA Approves Revised Indication for Allergan's OZURDEX®

September 29, 2014 10:06 am | News | Comments

Allergan announced today that the U.S. Food and Drug Administration (FDA) has approved OZURDEX® (dexamethasone intravitreal implant) 0.7 mg, a sustained-release biodegradable steroid implant, for the treatment of diabetic macular edema (DME).  

Alimera, pSivida say FDA Clears Eye Implant

September 26, 2014 5:45 pm | by The Associated Press | News | Comments

Alimera Sciences and pSivida said Friday the FDA approved their eye disease implant Iluvien....

AbbVie Gets Approval For Humira

September 26, 2014 10:48 am | News | Comments

The FDA cleared Humira as a treatment for moderate to severe Crohn's disease in children ages...

FDA Approves Eli Lilly's Injectable Diabetes Drug

September 18, 2014 4:46 pm | by The Associated Press | News | Comments

The Food and Drug Administration has approved a new injectable diabetes drug from Eli Lilly and...

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FDA Clears Constipation Drug Movantik

September 16, 2014 3:16 pm | News | Comments

Movantik, or naloxegol, is approved for adults who have chronic pain that is not caused by cancer. British drugmaker AstraZeneca PLC will market the drug, and it has also filed for regulatory approval in the European Union and Canada.   

FDA Approves Baxter’s HYQVIA for Treatment of Adults with Primary Immunodeficiency

September 15, 2014 8:31 am | News | Comments

Baxter International and Halozyme Therapeutics announced that the FDA approved Baxter’s subcutaneous treatment for adult patients with primary immunodeficiency (PI), HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase].

FDA Approves Weight-Loss Drug Contrave

September 11, 2014 8:13 am | News | Comments

The drug is approved for use by people who have a body mass index of 30 or higher, which is the level at which people are considered to be obese. It is also approved for use by people with a BMI of 27 or higher who also have a weight-related medical condition such as diabetes.

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Lilly Receives European Marketing OK for Insulin

September 10, 2014 10:58 am | News | Comments

European regulators have approved a long-lasting insulin from Eli Lilly and Co. and German drugmaker Boehringer Ingelheim that is the subject of patent infringement litigation with French rival Sanofi.        

FDA Approves Use of Menactra Vaccine for Booster Immunization Against Potentially Deadly Disease

September 8, 2014 2:55 pm | News | Comments

Sanofi Pasteur, the vaccines division of Sanofi, announced that the FDA has approved the use of Menactra [Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine] for booster vaccination against meningococcal disease in persons 15 years through 55 years of age.

FDA Approves Two New Indications for Epaned

September 8, 2014 9:54 am | News | Comments

Silvergate Pharmaceuticals today announced that the FDA approved Epaned (enalapril maleate Powder for Oral Solution) for the treatment of symptomatic heart failure and the treatment of asymptomatic left ventricular dysfunctio.    

Keryx Gets FDA Approval for New Kidney Disease Drug

September 5, 2014 12:06 pm | News | Comments

The FDA approved the company's ferric citrate drug to treat patients on dialysis with hyperphosphatemia, or elevated levels of phosphates, which can increase the risk of heart disease, bone density problems and death. Keryx estimates that between 350,000 and 375,000 U.S. dialysis patients take medication to control their phosphate levels, representing a total market of $1.2B.

FDA Approves Keytruda for Advanced Melanoma

September 4, 2014 3:49 pm | News | Comments

The U.S. Food and Drug Administration has granted accelerated approval to Keytruda (pembrolizumab) for treatment of patients with advanced or unresectable melanoma who are no longer responding to other drugs.       

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Pfizer and Protalix BioTherapeutics Announce FDA Approval of Pediatric Indication for ELELYSO™

August 28, 2014 1:41 pm | News | Comments

Pfizer and Protalix BioTherapeutics announced that the FDA approved ELELYSO™ for injection for pediatric patients. ELELYSO is therefore now indicated for long-term enzyme replacement therapy (ERT) for adult and pediatric patients with a confirmed diagnosis of Type 1 Gaucher disease.

European Commission Approves Bristol-Myers Squibb’s Daklinza

August 27, 2014 8:20 am | News | Comments

Bristol-Myers Squibb Company today announced that the European Commission has approved Daklinza (daclatasvir) for use in combination with other medicinal products across genotypes 1, 2, 3 and 4 for the treatment of chronic hepatitis C virus (HCV) infection in adults.

Ligand Partner GlaxoSmithKline Receives FDA Approval for Promacta®/Revolade™

August 27, 2014 8:07 am | News | Comments

Ligand Pharmaceuticals Incorporated announced that its partner GlaxoSmithKline has received approval of a supplemental New Drug Application (sNDA) for the once-daily use of Promacta®/Revolade™ (eltrombopag) in patients with severe aplastic anemia (SAA) who have had an insufficient response to immunosuppressive therapy (IST).

Fresenius Kabi Receives FDA Approval for Kabiven® and Perikabiven®

August 26, 2014 9:19 am | News | Comments

Fresenius Kabi announced today it has received approval from the U.S. Food and Drug Administration for Kabiven ® and Perikabiven ®, parenteral nutrition (PN) products in a three-chamber bag – the only container of its kind available in the United States.

FDA Approves Iroko Pharmaceuticals’ ZORVOLEX for Management of Osteoarthritis Pain

August 25, 2014 8:23 am | News | Comments

Iroko Pharmaceuticals, LLC,  announced today the United States Food and Drug Administration (FDA) has approved ZORVOLEX (diclofenac) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain.   

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FDA Approves New Sleeping Drug from Merck

August 13, 2014 4:29 pm | by The Associated Press | News | Comments

Merck & Co. has won federal approval for a new type of sleeping pill designed to help people with insomnia stay asleep. The tablet, Belsomra, works by temporarily blocking chemicals known as orexins that control the sleep cycle and can keep people awake at night.

FDA Approves Lung Preservation Machine

August 13, 2014 8:13 am | News | Comments

The Food and Drug Administration said Tuesday that the approval of the XVIVO Perfusion System could lead to more successful transplants of lungs for people with cystic fibrosis and other deadly respiratory diseases.      

FDA Approves DNA-Based Test for Colon Cancer

August 12, 2014 8:33 am | by MATTHEW PERRONE, AP Health Writer | News | Comments

The Cologuard test from Exact Sciences detects irregular mutations in stool samples that can be an early warning sign of cancer. Patients who test positive for the mutations should undergo a colonoscopy to confirm the results.    

FDA Approves INVOKAMET for the Treatment of Adults with Type 2 Diabetes

August 11, 2014 8:26 am | News | Comments

INVOKAMETT provides the clinical attributes of INVOKANA (canagliflozin), the first sodium glucose co-transporter 2 (SGLT2) inhibitor available in the United States, together with metformin, which is commonly prescribed early in the treatment of type 2 diabetes.

FDA Approves VELCADE® Retreatment in Patients with Multiple Myeloma

August 11, 2014 8:19 am | News | Comments

Millennium: The Takeda Oncology Company with its parent company, Takeda Pharmaceutical Company Limited, has announced that the FDA has approved VELCADE® for the retreatment of adult patients with multiple myeloma who had previously responded to VELCADE therapy and relapsed at least six months following completion of prior VELCADE treatment.

EU Approves EYLEA Injection for Diabetic Macular Edema

August 11, 2014 8:12 am | News | Comments

Regeneron Pharmaceuticals today announced that EYLEA (aflibercept) Injection has been approved by the European Commission for the treatment of visual impairment due to Diabetic Macular Edema (DME). Bayer Healthcare plans to launch EYLEA in DME in the EU this quarter.

FDA Approves ORBACTIV™ for Acute Bacterial Skin and Skin Structure Infections

August 7, 2014 8:43 am | News | Comments

The Medicines Company today announced that the FDA has approved ORBACTIV™ (oritavancin) 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).

European Commission Approves Octapharma’s Nuwiq® for Hemophilia A

August 6, 2014 8:44 am | News | Comments

The European Commission has published approval of Octapharma’s Nuwiq ® (simoctocog alfa) for the treatment and prophylaxis of bleeding in all age groups with hemophilia A (congenital factor VIII [FVIII] deficiency). Nuwiq ® is the newest generation of FVIII replacement, produced in a human cell line cultured without additives of human or animal origin.

FDA Approves Lannett's Oxycodone Hydrochloride Capsules 5 mg

August 4, 2014 8:59 am | News | Comments

Lannett Company today announced that it has received approval from the FDA of its Abbreviated New Drug Application (ANDA) for Oxycodone Hydrochloride Capsules, 5 mg, the therapeutic equivalent to the reference listed drug, Oxycodone Hydrochloride Capsules, 5 mg, of Lehigh Valley Technologies.

Genzyme Receives Label Expansion for Lumizyme® in the U.S. for the Treatment of Pompe Disease

August 4, 2014 8:40 am | News | Comments

Genzyme, a Sanofi company announced that the FDA approved a supplement to expand the indication for Lumizyme ® (alglucosidase alfa). Lumizyme manufactured at the 4000L scale is now indicated for all Pompe patients of any age or phenotype.  

FDA Approves Lilly, Boehringer Diabetes Drug

August 1, 2014 1:34 pm | by The Associated Press | News | Comments

Federal regulators have approved a new treatment from U.S. drugmaker Eli Lilly and Co. and its German counterpart, Boehringer Ingelheim, for the most common form of diabetes . The Food and Drug Administration said Friday it will permit Jardiance tablets to be used by adult patients with type 2 diabetes.

Hovione’s Cork, Ireland API Plant Passes FDA Pre- Approval Inspection

July 31, 2014 1:26 pm | News | Comments

The inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.              

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