Glenmark gets FDA OK for three drugs
MUMBAI, India — The Food and Drug Administration approved three drugs made by Glenmark Generics last month and gave tentative approval to a fourth, the Indian generic drug maker said.
On Dec. 23, the company announced the approval of the arthritis treatment indomethacin in the 25-mg and 50-mg strengths; sales for the drug were $20 million during the 12-month period ended in September 2010, according to IMS Health. The agency also approved sulfamethoxazole and trimethorprim double- and single-strength tablets, used to treat chronic bronchitis, bacterial infections and other conditions; sales for the drug were $31 million, according to IMS.
In addition, the FDA granted tentative approval for eszopiclone, a generic version of Sepracor’s insomnia treatment Lunesta, which had sales of $760 million, according to IMS. Tentative approval means that a generic drug meets the FDA’s conditions for approval, but the agency must wait to grant final approval until the branded drug loses patent protection.
On Dec. 28, the agency approved the company’s lithium carbonate extended-release tablets in the 300-mg strength. A generic version of Noven Therapeutics’ Lithobid, the drug is used to treat manic episodes in patients with bipolar disorder. Total sales for the drug were $21 million during the 12-month period ended in September 2010, according to IMS.
George W. Bush to deliver keynote speech at Armada summit
FLORHAM PARK, N.J. — Former president George W. Bush will deliver the keynote speech at Armada Health Care’s seventh annual Armada Specialty Pharmacy Summit, the specialty pharmacy contracting organization said.
The conference, which will take place May 10 to 13 at the Wynn Hotel in Las Vegas, is considered one of the top conferences in the U.S. drug industry.
“We are honored that President Bush will be speaking at our conference,” Armada CEO Lawrence Irene said. “As the largest gathering of industry stakeholders, our annual meeting offers the ideal agenda to gain a valuable insight into the rapidly growing specialty pharmacy channel. One of the highlights of our conference will certainly be the keynote address by [former president] Bush.”
FDA rejection of lower-dose Copaxone will likely ward off generic competition
NEW YORK — One door closes; another door, well, closes. And that appears to be good news for Teva. Recent news that the Food and Drug Administration has rejected the drug maker’s application for a new indication for multiple sclerosis drug Copaxone likely will mean the agency will not be so quick to approve a generic version of the drug without requiring a generic company to perform full clinical trials.
In its response to Teva, the FDA noted that it could not approve the application for a lower-dose from of Copaxone as the drug’s mechanism was not fully understood. "Unless you can provide a convincing argument that the new higher concentration/lower volume formulation does not have an impact on efficacy, an adequate and well-controlled efficacy study will be needed to support efficacy of this new formulation," the FDA noted.
“This response supports Teva’s belief that even slight changes to a glatiramoid like Copaxone can significantly and unpredictably influence the efficacy, toxicity and immunogenicity profile of the compound,” the company noted.
"The FDA’s letter highlighted the high hurdle potential generic manufacturers of Copaxone face in gaining approval," JP Morgan analyst Chris Schott noted in a Dec. 23 research note.