Content about Pharmaceutics

August 2, 2011

The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

EAST HANOVER, N.J. — The Food and Drug Administration has approved a new use for a drug made by Novartis for treating multiple sclerosis, the Swiss drug maker's U.S. subsidiary said Monday.

Novartis Pharmaceuticals announced the FDA's approval of Gilenya (fingolimod) for the reduction of T1 gadolinium-enhancing lesions, areas of inflammation in the central nervous system that mark disease activity in people with MS.

July 29, 2011

A generic version of a popular pneumonia treatment has entered the market from Hi-Tech Pharmacal.

AMITYVILLE, N.Y. — A generic version of a popular pneumonia treatment has entered the market from Hi-Tech Pharmacal.

Hi-Tech Pharmacal has introduced levofloxacin oral solution in the 25-mg/mL strength. The drug will be available in 480-mL, 200-mL and 100-mL sizes in order to allow pharmacists to tailor inventory to store volume. As previously reported by Drug Store News, Hi-Tech Pharmacal was granted tentative approval for the drug in April.

July 29, 2011

Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

JERUSALEM — Teva Pharmaceuticals has launched an authorized generic version of a contraceptive made by Duramed Pharmaceuticals, Teva said.

Teva announced the launch of Camrese, an authorized generic of Duramed’s Seasonique (levonorgestrel and ethinyl estradiol tablets and ethinyl estradiol tablets).

The launch of Teva’s authorized generic follows the launch of Watson Pharmaceuticals’ generic version of the drug, which it is marketing under the name Amethia.

July 28, 2011

Biogen Idec has expanded its online resource for patients living with multiple sclerosis to include new resources and support programs.

WESTON, Mass. — Biogen Idec has expanded its online resource for patients living with multiple sclerosis to include new resources and support programs.

MS ActiveSource features have expanded to include additional information and support on a range of issues, including financial assistance and nursing services. Additionally, the website also features a new online patient-to-patient community called ActiveVoices.

July 28, 2011

Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

INDIANAPOLIS — Drug makers Eli Lilly, Amylin Pharmaceuticals and Alkermes are giving their long-acting form of an injected drug for Type 2 diabetes another try at the Food and Drug Administration.

July 28, 2011

GlaxoSmithKline expects to close the deal on the divestiture of several over-the-counter brands that were identified in April, the company stated Tuesday as part of its second-quarter earnings results.

PHILADELPHIA — GlaxoSmithKline expects to close the deal on the divestiture of several over-the-counter brands that were identified in April, the company stated Tuesday as part of its second-quarter earnings results.

"The divestment of noncore OTC assets in the [United States] and Europe will further aid our strategy to accelerate growth and increase the focus of our Consumer Healthcare business," GSK stated. "We are making progress to divest these products by late 2011, subject to realizing appropriate value for shareholders."

July 28, 2011

Pfizer has entered a definitive agreement to acquire a biopharmaceutical company that focuses on the development of pain treatments.

NEW YORK — Pfizer has entered a definitive agreement to acquire a biopharmaceutical company that focuses on the development of pain treatments.

Pfizer, which currently owns a near 11% stake in Icagen, will acquire the company's remaining 8.3 million shares. The aggregate transaction value, which includes the value of the shares currently owned by Pfizer, is about $56 million.

The two companies entered a discovery, development and commercialization collaboration in 2007, which sought to create potential treatments for pain and related disorders.

July 28, 2011

The president and CEO of Sanofi's U.S. operations is stepping into a newly created role at the drug maker.

PARIS — The president and CEO of Sanofi's U.S. operations is stepping into a newly created role at the drug maker.

Greg Irace will become SVP global services, leading the global information systems function and will be responsible for shared support functions across all Sanofi businesses in North America. He also will play a key role in the development of a global strategy for shared services. Irace will report to Jérôme Contamine, Sanofi EVP and CFO.

July 26, 2011

Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

OSAKA, Japan — Japanese drug maker Takeda Pharmaceutical is reapplying for approval of two drugs to treat Type 2 diabetes after the Food and Drug Administration turned down its last applications, the company said.

Takeda announced that it resubmitted its applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in Actos, which the FDA approved in 1999.

The FDA will review the applications over the next six months, the drug maker said.

July 26, 2011

Watson Pharmaceuticals had sales of $1.1 billion during second quarter 2011, the generic drug maker said.

PARSIPPANY, N.J. — Watson Pharmaceuticals had sales of $1.1 billion during second quarter 2011, the generic drug maker said.

In a financial report released Tuesday, Watson said the sales figures for the quarter represented a 24% increase over sales in second quarter 2010. Profit for the quarter was $52.4 million, compared with $70.6 million in second quarter 2010.

“Our record $1 billion in net revenues in the second quarter demonstrates the strength of our combined global generics and global brands strategies,” Watson president and CEO Paul Bisaro said.

July 25, 2011

The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said.

SUPPLIER NEWS — The Food and Drug Administration has approved a drug made by Johnson & Johnson for treating deep vein thrombosis in patients undergoing knee or hip replacement surgery, a J&J subsidiary said. Janssen Pharmaceuticals announced the approval of Xarelto (rivaroxaban) tablets as a once-daily oral anticoagulant for DVT, a condition that could lead to pulmonary embolism.


July 15, 2011

The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

HYDERABAD, India — The Food and Drug Administration has approved a generic anticoagulant drug made by Dr. Reddy’s Labs and Alchemia.

Dr. Reddy’s and Brisbane, Australia-based Alchemia announced the FDA approval of fondaparinux sodium injection in the 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL strengths. Alchemia owns the patents covering the process for synthesis of fondaparinux.

July 15, 2011

Teva Pharmaceutical Industries has completed its acquisition of Japan’s third-largest generics company, Teva said.

JERUSALEM — Teva Pharmaceutical Industries has completed its acquisition of Japan’s third-largest generics company, Teva said.

The Israeli drug maker, the world’s largest maker of generic drugs, announced that it had acquired effectively all the outstanding shares of Taiyo Pharmaceutical Industry Co. for $934 million.

July 14, 2011

French drug maker Sanofi has sold its skin care business to Canada’s Valeant Pharmaceuticals International, Sanofi said.

PARIS — French drug maker Sanofi has sold its skin care business to Canada’s Valeant Pharmaceuticals International, Sanofi said.

Sanofi said the $425 million sale of its dermatology business, Dermik, would allow it to focus on its core businesses. Valeant’s business is much more focused on dermatology, as well as neurology, than Sanofi’s is.

July 7, 2011

Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

DARMSTADT, Germany — Merck KGaA division Merck Serono has appointed Belen Garijo as COO and Annalisa Jenkins as global head of drug development and medical, effective Sept. 5.

The company, which operates under the name "EMD" in the United States and is a separate company from U.S.-based Merck, said Garijo and Jenkins will be based in Geneva and will report to president Stefan Oschmann.

Garijo previously worked for Sanofi, where he was SVP global operations for the European region, while Jenkins was SVP global medical for Bristol-Myers Squibb.

June 28, 2011

A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

CORK, Ireland — A subsidiary of Johnson & Johnson and Gilead Sciences will collaborate to develop a combination drug for HIV, the two companies said Tuesday.

Gilead and Tibotec Pharmaceuticals will work to create a once-daily, single-tablet combination of Tibotec’s Prezista (darunavir) and Gilead’s investigational drug cobicistat, a so-called boosting agent.

June 28, 2011

Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

AMITYVILLE, N.Y. — Generic drug maker Hi-Tech Pharmacal said that it has acquired marketing and distribution rights to pain treatments made by Atley Pharmaceuticals.

Hi-Tech, which paid $3.6 million in cash for rights to the products and inventory, said some of Atley's drugs already have been approved by the Food and Drug Administration, while others were pending approval. The company didn't say which products it was acquiring the rights to, but noted that Hi-Tech subsidiary ECR Pharmaceuticals will produce and promote the products.

June 24, 2011

The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

NEW YORK — The Food and Drug Administration has declined to approve an investigative painkiller made by Pfizer, the drug maker said Friday.

The FDA issued a complete response letter for Remoxy (oxycodone) extended-release capsules, which Pfizer is developing under a partnership with Pain Therapeutics. Pain Therapeutics originally developed the drug using Durect’s Oradur technology, which is designed to prevent tampering by drug abusers, in collaboration with King Pharmaceuticals. Pfizer took control of development of the drug when it acquired King in February.

June 22, 2011

Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

HYDERABAD, India — Generic drug maker Dr. Reddy’s Labs has launched its version of a popular antibiotic.

The company said its levofloxacin tablets in the 250-mg, 500-mg and 750-mg strengths have entered the market, following the Food and Drug Administration's approval of Dr. Reddy's abbreviated new drug application. Dr. Reddy's levofloxacin tablets in the 250-mg and 500-mg strengths are available in 50-count bottles, while the 750-mg strength bottle is available in 30-count bottles.

June 21, 2011

The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

SILVER SPRING, Md. — The Food and Drug Administration Tuesday approved the first generic versions of an antibiotic designed to treat certain infections in people ages 18 years and older.

June 21, 2011

Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

PARSIPPANY, N.J. — Watson subsidiary Watson Labs is seeking approval for a drug designed to treat symptomatic benign prostatic hyperplasia in men with an enlarged prostate.

The company filed an abbreviated new drug application to market dutasteride capsules in the 0.5-mg strength. The drug is a generic version of Avodart, which is made by GlaxoSmithKline.

June 20, 2011

A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

TARRYTOWN, N.Y. — A panel of Food and Drug Administration experts has recommended approval of an investigational biotech drug made by Regeneron Pharmaceuticals for eye diseases.

Regeneron said Friday that the FDA’s Dermatologic and Ophthalmic Drugs Advisory Committee unanimously recommended approval of Eylea (aflibercept) ophthalmic solution for the treatment of a form of age-related macular degeneration, also known as wet AMD. The disease causes abnormal growth of new blood vessels in the eye.

June 20, 2011

Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

TITUSVILLE, N.J. — Johnson & Johnson is recalling 40,000 bottles of a drug used to treat schizophrenia due to consumer reports of the drug having a strange odor, the company said Friday.

J&J subsidiary Ortho-McNeil-Janssen Pharmaceuticals announced the voluntary recall of one lot of Risperdal (risperidone) tablets in the 3-mg strength and a lot of authorized generic risperidone tablets in the 2-mg strength made by Patriot Pharmaceuticals, also a J&J subsidiary.

June 17, 2011

A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

PARSIPPANY, N.J. — A federal court has rejected Teva Pharmaceutical Industries’ efforts to prevent Watson from launching a generic version of one of its drugs, Watson said Friday.

The U.S. District Court for the District of Nevada denied Duramed Pharmaceuticals’ request for an injunction to keep Watson’s generic version of the contraceptive Seasonique (levonorgestrel and ethinyl estradiol 0.15 mg/0.03 mg) and ethinyl estradiol 0.01 mg from being launched.

Seasonique is made by Teva Women’s Health, the successor of Duramed.

June 15, 2011

The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

HYDERABAD, India — The Food and Drug Administration has issued a warning letter to Dr. Reddy’s Labs’ chemical manufacturing plant in Mexico, the company said Tuesday.

The drug maker said Dr. Reddy’s subsidiary Industrias Quimicas Falcon de Mexico, in Cuernavaca, received an FDA warning letter based on a November 2010 inspection where the regulatory agency found a number of manufacturing problems.

Dr. Reddy’s said it takes the warnings seriously and will respond to the FDA and work with the agency to resolve the problems.