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 The leading web portal for pharmacy resources, news, education and careers January 20, 2017
Pharmacy Choice - News - U.S. FDA Final Approvals (Drugs & Devices) - January 20, 2017

Pharmacy News

 U.S. FDA Final Approvals (Drugs & Devices)
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1/19/17 - U.S. FDA Approves IMBRUVICA (ibrutinib) as First Treatment Specifically Indicated for Relapsed/Refractory Marginal Zone Lymphoma (MZL) - a Rare Type of Non-Hodgkin's Lymphoma
AbbVie, a global biopharmaceutical company, today announced the U.S. Food and Drug Administration approved IMBRUVICA for the treatment of patients with relapsed/refractory marginal zone lymphoma who require systemic therapy and have received at least one prior anti-CD20-based therapy. 1 This indication is approved under accelerated approval ba
1/19/17 - UCB files BRIVIACT (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patients with partial-onset seizures
BRUSSELS and ATLANTA, Jan. 19, 2017/ PRNewswire/ UCB has today announced the filing of a supplemental New Drug Application to the U.S. Food and Drug Administration for BRIVIACT CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.. The FDA's agreement to the principle o
1/19/17 - Volume Growth Key for Hemostasis and Tissue Sealing Agents Market Likely to Touch US$5.2 Bn in 2020
Albany, NY 01/18/2017 Hemostasis and tissue sealing agents play a vital role in simplifying wound sealing procedures during surgeries. For example, in May 2014, the Sylys Surgical Sealant was introduced by Cohera Medical, Inc.; it can be used in gastrointestinal surgery. In January 2014, Baxter received the U.S. FDA approval for the TISSEEL f
1/19/17 - WellDoc Receives FDA 510(k) Clearance to Offer a Non-Prescription Versionof BlueStar Digital Therapeutic for Type 2 Diabetes
Digital health leader WellDoc announced today that the U.S. Food and Drug Administration has granted the Company 510 class II clearance for a non-prescription version of the BlueStar digital therapeutic. This BlueStar option will allow WellDoc more flexibility in offering the product through additional channels to adults living with type 2.
1/18/17 - Hikma's Unit Roxane Gets US Approval For Generic Sodium Oxybate Oral Solution
LONDON- Hikma Pharmaceuticals Plc announced Wednesday that its unit Roxane Laboratories, Inc. has received an approval from the US Food and Drug Administration for its Sodium Oxybate Oral Solution, 500 mg/mL, the generic equivalent to Xyrem. Roxane is currently involved in patent litigation concerning this product in the US District Court for the D
1/18/17 - Jazz Pharma To Evaluate If Generic Xyrem's FDA Waiver Meets Required Legal Conditions
The FDA announced late Tuesday that it approved the first generic version of Xyrem, sodium oxybate, oral solution to treat cataplexy and excessive daytime sleepiness in patients with narcolepsy. A Reuters report stated that the manufacturer of the generic version was identified as Roxane Laboratories by the FDA. The latter had received FDA approval
1/18/17 - Q&A with Stephen Prescott: New drug approvals slide in 2016 [The Oklahoman, Oklahoma City]
Q: Last year, the Food and Drug Administration approved 22 new drugs. Over the previous five years, the FDA had approved an average of 36 new drugs a year, so this was a big step back. The class of 2015 included five drugs that weren't supposed to receive a thumbs up or down from the FDA until 2016, but the approval process was accelerated for them
1/18/17 - Teva Receives FDA Approval for VANTRELATM ER (Hydrocodone Bitartrate) Extended-Release Tablets [CII] Formulated with Proprietary Abuse Deterrence Technology
Teva Pharmaceutical Industries Ltd. today announced the U.S. Food and Drug Administration approved VANTRELA TM ER extended-release tablets formulated with Teva s proprietary abuse deterrence technology. Teva understands the risk of prescription drug abuse is a challenge healthcare professionals face when treating millions of Americans affecte
1/18/17 - Underarm Odor Banned with Newly Cleared FDA Treatment
But the advent of a newly FDA- cleared device to permanently eradicate glands causing the condition is cause for celebration among those who have suffered its negative impact on their body, clothing and self-esteem, according to dermatology specialists Joshua Fox, MD, and Meryl Joerg, MD, of Advanced Dermatology P.C.. Under the arms, in particular,
1/17/17 - Referencing Approved Drug Products in Abbreviated New Drug Application Submissions; Draft Guidance for Industry; Availability
SUMMARY: The Food and Drug Administration is announcing the availability of a draft guidance for industry entitled "Referencing Approved Drug Products in ANDA Submissions." DATES: Although you can comment on any guidance at any time, to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version o
1/16/17 - Keystone Nano Announces FDA Approval Of Investigational New Drug Application For Ceramide NanoLiposome For The Improved Treatment Of Cancer
By a News Reporter-Staff News Editor at Clinical Trials Week- Keystone Nano, Inc., a biopharmaceutical company focused on improving cancer treatments through the application of nanotechnology, announced that the U.S. Food and Drug Administration has approved the company's Investigational New Drug Application to assess Ceramide NanoLiposome in the
1/16/17 - Roche launches cobas c 513 analyzer and HbA1c Gen. 3 assay to meet increasing demand for testing of people with diabetes
By a News Reporter-Staff News Editor at Diabetes Week- Roche announced that its new dedicated, high-throughput HbA1c testing solution, the cobas c 513 analyzer, and HbA1c Gen. 3 assay has received 510 clearance from the U.S. Food and Drug Administration. "With the FDA approval of the new cobas c 513 analyzer and proven HbA1c Gen. 3 assay, Roche
1/16/17 - U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for Synjardy empagliflozin/metformin hydrochloride,...
U.S. FDA approves supplemental New Drug Applications to include landmark data in product labels for Synjardy empagliflozin/metformin hydrochloride, Synjardy XR empagliflozin/metformin hydrochloride extended-release and Glyxambi empaglif. By a News Reporter-Staff News Editor at Diabetes Week- The U.S. Food and Drug Administration approved
1/16/17 - VetDC Receives FDA Conditional Approval of TANOVEA?-CA1, the First New Animal Drug for Treating Lymphoma in Dogs
By a News Reporter-Staff News Editor at Pharma Business Week VetDC, Inc., a veterinary cancer therapeutics company, announced that the U.S. Food and Drug Administration's Center for Veterinary Medicine has granted a conditional approval of Tanovea?- CA1 for the treatment of lymphoma in dogs. "This is a significant milestone for VetDC, and we a
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