Sagent announces FDA approval for azithromycin for injection
SCHAUMBURG, Ill. Sagent Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that the Food and Drug Administration approved its antibiotic, designed to treat a wide variety of bacterial infections.
Sagent will offer azithromycin for injection, a semi-synthetic, macrolide in a 500 mg vial for intravenous use. The company anticipates the launch of the product by next month.
Under a joint venture agreement with Strides Arcolab, the companies are developing, supplying and marketing more than 25 injectable products for the U.S. market. Strides is responsible for developing and supplying injectable products that Sagent will market in the United States.
“This approval marks an important milestone for Sagent, as azithromycin is the first product from our joint venture – established in 2007 – with Strides Arcolab,” said Jeffrey M. Yordon, CEO, founder, and chairman of the board at Sagent. “Strides’ manufacturing and development expertise will be invaluable as we move forward with not only azithromycin, one of the world’s most widely used antibiotics, but also with the more than 25 products under development by the joint venture.”
According to IMS sales data, 2008 sales of azithromycin in the United States approximated $42 million.
Two new diabetes drugs to be reviewed by FDA next week
NEW YORK The Food and Drug Administration’s Endocrinologic and Metabolic Drugs Advisory Committee will review two new diabetes drugs next week, and this has left investors nervous, according to published reports.
On April 1, the committee will review Onglyza (saxagliptin), by AstraZeneca and Bristol-Myers Squibb, and review Victoza (liraglutide) the next day. According to Reuters, however, an FDA rejection earlier this month of Takeda Pharmaceutical’s alogliptin calling for additional clinical data, caused the company’s stock to fall.
According to the news agency, an analyst said that the FDA might be slow to approve drugs similar to those on the market. Onglyza is a DPP-4 inhibitor, belonging to the same class as alogliptin; Merck & Co.’s DPP-4 inhibitor Januvia (sitagliptin) is already on the market.
Mylan confirms first-to-file challenges
PITTSBURGH Mylan could get exclusive rights to four generic drugs.
The generic drug maker confirmed Thursday that six drug companies and two research centers had sued it in connection with four “first-to-file” regulatory approval applications containing Paragraph IV certifications.
- Sepracor sued Mylan and Alphapharm in the U.S. District Court of New Jersey over an application for eszopiclone tablets in the 1 mg, 2 mg and 3 mg strengths. The tablets are a generic version of the insomnia drug Lunesta, which had sales of $796 million in 2008, according to IMS Health.
- Shire sued Mylan and subsidiary Matrix Labs in the U.S. District Court for the Southern District of New York over an application for lanthanum carbonate chewable tablets in the 500 mg, 750 mg and 1 g strengths. The tablets, used to treat kidney disease, are a generic version of Fosrenol, which had sales of $108 million in 2008, according to IMS Health.
- OSI Pharmaceuticals, Pfizer and Genentech sued Mylan in the U.S. District Court in Delaware over an application for erlotinib hydrochloride tablets in the 25 mg, 100 mg and 150 mg strengths. The tablets, used to treat lung cancer, are a generic version of Tarceva, which had sales of $492 million in 2008, according to IMS Health.
- Galderma Labs, New York University and the Research Foundation of the State University of New York sued Mylan in the U.S. District Court of Delaware over an application for doxycycline delayed-release capsules in the 40 mg strength. The capsules are a generic version of Galderma’s adult rosacea treatment Oracea, which had sales of $82 million in 2008, according to IMS Health.
Under the Hatch-Waxman Act of 1984, the first company to seek approval for a generic version of a drug gets six months of market exclusivity once the generic drug gets final approval from the Food and Drug Administration. A Paragraph IV certification asserts that a branded company’s patent on a drug is invalid, unenforceable or won’t be infringed by a generic version.