Watson seeks to commercialize generic Avodart
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.
GlaxoSmithKline last Friday confirmed that it filed suit against Watson under the Hatch-Waxman Act in the U.S. District Court for the District of Delaware. GSK is seeking to prevent the generic drug maker from commercializing its dutasteride capsules prior to the expiration of patent No. 5,565,467. GSK is hoping for a stay of final FDA approval of Watson’s ANDA until Nov. 17, 2013, or until final resolution of the matter before the court, whichever occurs sooner.
For the 12 months ended April 30, Avodart had total U.S. sales of approximately $580 million, according to IMS Health data.
Shoppers Food & Pharmacy gets green light for Superfresh store bid
BOWIE, Md. — Shoppers Food & Pharmacy on Tuesday announced that its bid to purchase a Superfresh store in Ellicott City, Md., was approved by the court handling the ongoing A&P bankruptcy proceedings.
"We are excited to become part of the Ellicott City community," Shoppers president Tim Lowe said. "We’re looking forward to serving our new neighbors and friends with a special local focus that can come only from a neighborhood grocer."
Now that the deal has been approved, Shoppers expects to take possession of the store on July 7. The store pharmacy will open on July 7, and the store is scheduled to reopen to the public by July 17.
Shoppers is planning to remodel the store during the summer and will host a grand reopening celebration later this year.
Shoppers is part of the Supervalu family of grocery stores.
FDA approves first generic versions of Levaquin
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.
Generic tablet, oral solution, and injectable solution dosage forms of levofloxacin have been approved, the FDA said. Levofloxacin is used to treat mild, moderate, or severe bacterial infections of the skin, sinuses, kidneys, bladder, and prostate caused by specific germs. It also is used to treat certain bacterial infections that cause bronchitis or pneumonia, and to treat those exposed to inhalational anthrax.
Levofloxacin is a generic version of Levaquin, which is marketed by Ortho-McNeil-Janssen Pharmaceuticals. The following 12 manufacturer’s applications for generic Lexaquin have been approved:
Dr. Reddy’s Labs;
Torrent Pharmaceuticals; and