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Bevespi Aerosphere™ approved by the US FDA for patients with COPD

DosagePIPELINEREVIEW2016-04-26 17:22 Read   415

AstraZeneca today announced that the US Food and Drug Administration has approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation aerosol indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Synthon obtains approval for glatiramer acetate 20 mg/mL in Europe

DosageSynthon2016-04-13 10:45 Read   193

Synthon today announced that it has successfully concluded the decentralized procedures for glatiramer acetate, a therapeutically equivalent version of the originator medicine Copaxone®* for the treatment of relapsing remitting multiple sclerosis (RRMS).

FDA Grants Spectrum Pharmaceuticals Approval of EVOMELA™ (melphalan) for Injection

DosageSpectrum Pharmaceuticals2016-03-16 13:23 Read   185

Spectrum announced today that the U.S. FDA has granted approval of EVOMELA for use in two indications。

Allergan Announces FDA Approval of ACZONE® (dapsone) Gel, 7.5% for Treatment of Acne Vulgaris

DosageAllergan2016-02-29 17:16 Read   179

Allergan plc , a leading global pharmaceutical company, today announced that the Company has received approval from the U.S. FDA to market ACZONE® (dapsone) Gel, 7.5%, a new prescription topical treatment for acne in patients 12 years of age and older.

Pfizer Announces FDA Approval of XELJANZ® XR (tofacitinib citrate) Extended-Release Tablets, the First and Only Once-Daily Oral JAK Inhibitor Treatment for Rheumatoid Arthritis

DosagePfizer2016-02-26 09:29 Read   811

Pfizer Inc. (NYSE:PFE) announced today that the U.S. FDA has approved XELJANZ® XR extended-release 11 mg tablets for the once-daily treatment of moderate to severe rheumatoid arthritis (RA) in patients who have had an inadequate response or intolerance to methotrexate (MTX).

Brilique (ticagrelor) approved in EU for extended treatment of patients with history of heart attack

DosageAstraZeneca2016-02-23 10:53 Read   572

AstraZeneca today announced that the European Commission has granted marketing authorisation for Brilique (ticagrelor) at a new 60mg dose for the treatment of patients who have suffered a heart attack at least one year prior and are at high risk of developing a further atherothrombotic event.

FDA Approves Merck’s Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)

DosageMerck2016-02-05 11:21 Read   303

FDA Approves Merck’s Single-Dose EMEND® (fosaprepitant dimeglumine) for Injection, in Combination with Other Antiemetic Agents, for the Prevention of Delayed Nausea and Vomiting in Adults Receiving Moderately Emetogenic Chemotherapy (MEC)

FDA Approves Takeda's Dexilant SoluTab (dexlansoprazole)

DosageTakeda2016-02-01 15:48 Read   317

New melt in your mouth tablet for appropriate adult patients with heartburn associated with Gastroesophageal Reflux Disease (GERD)

FDA moves quickly to approve easy-to-use nasal spray to treat opioid overdose

DosageFDA2015-11-19 10:27 Read   287

Today the U.S. Food and Drug Administration approved Narcan nasal spray, the first FDA-approved nasal spray version of naloxone hydrochloride, a life-saving medication that can stop or reverse the effects of an opioid overdose.

Collegium Announces FDA Tentative Approval for Xtampza(TM) ER, a Novel Abuse-Deterrent Analgesic for Chronic Pain

DosageCollegium2015-11-10 15:26 Read   718

Collegium Pharmaceutical, Inc. today announced that the United States Food and Drug Administration (FDA) has granted tentative approval to the Company's New Drug Application (NDA) for Xtampza(TM) ER (oxycodone) extended-release capsules for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

RedHill Biopharma and IntelGenx Announce First European Marketing Approval of RIZAPORT (RHB-103) for Migraines

DosageRedHill2015-11-10 10:47 Read   432

 The national approval of RIZAPORT™ in Germany was granted under the European Decentralized Procedure (DCP), in which Germany served as the Reference Member State. This authorization is the first national marketing approval of RIZAPORT™.

Iroko Pharmaceuticals Receives FDA Approval for VIVLODEX- First Low Dose SoluMatrix? Meloxicam for Osteoarthritis Pain

Dosagepipelinereview2015-10-26 13:53 Read   480

October 23, 2015, Iroko Pharmaceuticals, LLC announced today that the United States Food and Drug Administration (FDA) approved VIVLODEX (meloxicam) capsules, a nonsteroidal anti-inflammatory drug (NSAID), for the management of osteoarthritis pain in 5 mg and 10 mg doses administered once daily.