US-based Mylan Pharmaceuticals has introduced generic equivalent to Micronor tablets, 0.35mg (28-day cycle) indicated for the prevention of pregnancy in the US. Norethindrone Tablets USP, 0.35mg, are the generic version of Janssen ...
Tags: Generic Micronor Tablets, Medicine
The FDA has approved the use of Astellas Pharma US' Mycamine (micafungin sodium) for injection to treat pediatric patients aged four months and more with candidemia, acute disseminated candidiasis, Candida peritonitis and abscesses, ...
The USFDA has accepted Pfizer's supplemental new drug application (sNDA) to expand labeling of rheumatoid arthritis medication Xeljanz (tofacitinib citrate) to include inhibition of structural damage progression. The data from ORAL Start ...
Tags: FDA, Pfizer sNDA, Xeljanz Labeling
The US Food and Drug Administration (FDA) has accepted the new drug application (NDA)from DURECT, a specialty pharmaceutical company, for its Posidur (Saber-Bupivacaine) investigational candidate. Designed to offer up to three days of ...
Our recent recommendation that you might want to skip the new weight-loss drug Belviq has generated a lot of buzz. To follow up, we commissioned two Dartmouth professors to look at the evidence and prepare a Drug Facts box for Belviq, ...
Tags: Belviq, Weight-Loss Drug, Health&Medicine
Pharmaceutical packaging requires high attention to detail due to the critical nature of the materials required to protect the active product throughout its shelf life. Types of packaging material and design can also be influenced by the ...
Tags: Pharmaceutical Packaging, Packaging, Packaging Machinery
Daiichi Sankyo Company is seeking approval for an oral antiplatelet agent prasugrel hydrochloride to treat ischemic heart diseased patients undergoing percutaneous coronary intervention (PCI) in Japan. The company has submitted a new drug ...
Tags: Daiichi Sankyo, Medicine
Chengdu Huasun Group Inc., Ltd. (SZSE: 000790) announced yesterday that its biological tech subsidiary has been supported by China in doing an anticancer research. The research is concerned with the utilization of Iodine [131I] Metuximab ...
Tags: Health, Medicine, Anticancer Product
Specialty pharmaceutical company TherapeuticsMD has obtained investigational new drug (IND) application clearance from the US Food and Drug Administration (FDA) for vaginal estradiol suppository, TX12-004HR. The IND acceptance will allow ...
The US Food & Drug Administration (FDA) has issued a tentative approval letter to Supernus Pharmaceuticals for its Trokendi XR (extended release topiramate) in the treatment of epilepsy. Following to completion of review of the Trokendi ...
Tags: Supernus Trokendi, FDA Approval
AstraZeneca has agreed to purchase California-based respiratory medication developer, Pearl Therapeutics, in a deal with a total potential cost of up to $1.15bn. As per the definitive agreement signed between both the parties, AstraZeneca ...
Tags: AstraZeneca, Pearl Therapeutics
Biopharmaceutical company Gilead Sciences has obtained priority review status for Sofosbuvir new drug application (NDA) from the FDA for the treatment of hepatitis C infection (HCV). The investigational product is an oral nucleotide ...
Tags: Gilead, Sofosbuvir NDA
The FDA has cleared Celgene's supplemental new drug application (sNDA) for Revlimid (lenalidomide) for the treatment of patients with relapsed or refractory mantle cell lymphoma (MCL). The approval follows positive data from MCL-001 phase ...
Specialty pharmaceutical company Sun Pharmaceutical Industries has obtained final USFDA approval for the abbreviated new drug application of generic Depo-Testosterone Injection, Testosterone Cypionate Injection USP, 100mg/ml and 200mg/ml. ...
Danish biotechnology company Zealand Pharma and partner, the Swiss pharma group Helsinn have jointly cHelsinn's Phase IIa study with elsiglutide for the prevention of chemotherapy-induced diarrhea in cancer patients has been completed with ...
Tags: Health, Medicine, biotechnology