The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Generic Drug User Fee Amendments of 2013, authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, for certain generic new animal drug products, and for certain sponsors of such abbreviated applications for generic new animal drugs and/o
LONDON Anglo-Swedish drugmaker AstraZeneca says second-quarter earnings fell 22 per cent after sales of its blockbuster cholesterol drug Crestor dropped sharply after a generic alternative came on the market in the United States.
Anglo-Swedish drugmaker AstraZeneca says second-quarter earnings fell 22 percent after sales of its blockbuster cholesterol drug Crestor dropped sharply after a generic alternative came on the market in the United States. Core operating profit, which excludes one-time items such as restructuring costs and impairments, dropped to $1.41 billion fr
The Federal Food, Drug, and Cosmetic Act, as amended by the Biosimilar User Fee Act of 2012, authorizes FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, certain applications and supplements for approval of biosimilar biological products, establishments where approved biosimilar
WASHINGTON, July 28 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. The Federal Food, Drug, and Cosmetic Act, as amended by the Animal Generic Drug User Fee Amendments of 2013, authorizes FDA to collect user fees for certain abbreviated applications for gen
WASHINGTON, July 28 The Department of Health and Human Services published the following notice in the Federal Register from the Food and Drug Administration:. Dates: No later than 5 calendar days after FDA grants the sponsor's request for a BPD meeting for that product, or upon the date of submission of an IND describing an investigation that FDA
WASHINGTON- Gland Pharma Limited, an Indian pure-play generic injectable pharmaceutical products company, announced a definitive agreement under which Shanghai Fosun Pharmaceutical Co. Ltd., a Chinese health care provider, will acquire an approximate 86% stake in Gland for up to $1.26 billion. Fosun Pharma will purchase all shares of Gland owned by
Frontage Laboratories, Inc. announced that it has established a joint venture with Zhejiang Jiuzhou Pharmaceutical Co., Ltd. to provide enhanced access to high quality and economical API& intermediate development and manufacturing services to new US clients focused on New Chemical Entities and vertically-integrated generic APIs that are developed..
Gland Pharma Limited, a leading Indian pure-play generic injectable pharmaceutical products company, today announced the signing of a definitive agreement under which Shanghai Fosun Pharmaceutical Co. Ltd., a leading Chinese health care provider, will acquire an approximate 86% stake in Gland for up to US $1.26 billion. Ravi Penmetsa, will continue
Glenmark Pharma ended 0.3% higher at Rs.853.05 on BSE after the company s parent company received FDA nod for new drug. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food& Drug Administration for Potassium Chloride Extended-Release Tablets USP, 10 mEq and 20 mEq, the generic version of K-Dur Extended-Rel
-Hemispherx Biopharma announced today that it has reached an agreement with Avrio Biopharmaceuticals, Irvine California, to serve as an additional contract manufacturer of Hemispherxs experimental drug, Ampligen, also known by its generic name rintatolimod. Avrio, an FDA inspected facility, has the capabilities for the compounding and fill/finish o
In November 2010, Jazz Pharmaceuticals, Inc., a wholly owned subsidiary of the Company, filed a lawsuit in the United States District Court for the District of New Jersey against Roxane Laboratories, Inc. seeking a permanent injunction to prevent Roxane from introducing a generic version of Xyrem that would infringe the Company's patents.
Korea Kolmar has signed an agreement with Abbott Korea for the exclusive supply of drugs, it announced on July 27. The domestic market for pregabalin, known to be effective for reducing central neuropathic pain, is estimated to be 43 billion won. And when Pfizers patent for the use of pregabalin in the neuropathic pain in adults, branded under Lyri
Biogen, a U.S. multinational biotechnology company, announced its second-quarter results last Friday, including the sales records of Benepali, an arthritis drug developed by Samsung Bioepis and marketed by it in Europe. Samsung Bioepis has been making Benepali, its first biosimilar product, in Biogen's factory in Denmark. Sales of Inflectra, a rheu
July 28 Mylan NV is divesting two generic drugs to resolve concerns from U.S. regulators that its acquisition of Swedish specialty drugmaker Meda AB would have led to higher prices for the medicines. Mylan, which is based in the Netherlands and run from offices in Cecil, agreed to sell the rights and assets related to generic felbamate, a treatme
AHMADABAD, GUJARAT, INDIA, July 28, 2016/ EINPresswire.com/ The unholy nexus between drug makers and doctors to prevent affordable generic medicines reaching poor is a blatant violation of Medical Council of India s directives and also against the Constitution, which guarantees citizen their right to access quality, safe and affordable medicin
The marketing rights being sold to Xantis Pharma include a wide range of products covering cardiovascular, pain management, urology and sexual health indications, said Jeremy Drummond, sales and marketing director at Saneca. These are generic products that Saneca has developed and registered in East European markets, he told in-pharmatechnologist.c
Teligent, Inc., a New Jersey- based specialty generic pharmaceutical company, today announced its financial results for the second quarter ended June 30, 2016. Total revenues of $17.1 million in the second quarter of 2016, an increase of 93% over the same quarter in 2015. Total net revenues generated from the sale of our generic topical and injec
Teva Pharmaceutical Industries Ltd. has agreed to sell the rights and assets related to 79 pharmaceutical products to settle FTC charges that its proposed $40.5 billion acquisition of Allergan plcs generic pharmaceutical business would be anticompetitive. The FTC order will preserve competition in U.S. pharmaceutical markets where Teva and Allergan
The divestiture is the largest ever in an FTC pharmaceutical merger case, according to the FTC. A spokeswoman for Israel- based Teva declined to comment on the divestiture Wednesday, but the drugmaker did issue a release Wednesday announcing that its agreement with the FTC will allow it to acquire Allergan`s generics business, known as Actavis Gene
PETAH TIKVA- Teva Pharmaceutical Industries Ltd., and Allergan plc announced that the U.S. Federal Trade Commission or FTC has accepted the proposed consent order in connection with the pending acquisition of Allergan's generics business by Teva Pharmaceutical Industries Ltd.. Once the transaction is completed, Teva will have approximately 338 prod
Teva Pharmaceutical Industries Ltd., and Allergan plc today announced that the U.S. Federal Trade Commission has accepted the proposed consent order in connection with the pending acquisition of Allergans generics business by Teva Pharmaceutical Industries Ltd.. Mr. Vigodman continued, The new Teva will be ideally positioned to realize the...
July 28 Teva Pharmaceutical Industries Ltd. last night announced that the US Federal Trade Commission had consented to its acquisition of Allergan's generics business. The FTC said that Teva had satisfied the regulatory approval requirements under the purchase agreement to complete the acquisition of Actavis Generics. Last week, Teva raised over
WASHINGTON, U.S.- Israeli pharmaceutical company, Teva, with the nod from the U.S. Federal Trade Commission, has inked a deal worth $40.5 billion to acquire the generic business of Allergen. The divestment of drugs like anesthetics, antibiotics, weight-loss drugs and oral contraceptives will benefit over 11 companies which include Mayne Pharma Grou
Israeli pharmaceutical company wins regulatory approval for acquisition of Allergan, conditional upon giving up some of its products. The Federal Trade Commision, has approved Israeli-based pharmaceutical company Teva's acquisition of Allergan's generic drug production business, after a yearlong bid to win the approval of the regulatory body, the W