Teva receives FDA approval for acne medication
JERUSALEM The Food and Drug Administration has approved a generic version of an acne medication.
Teva Pharmaceutical Industries announced that the FDA had approved its version of Medicis Pharmaceutical Corp.’s Solodyn (minocycline hydrochloride) extended-release tablets in the 45 mg, 90 mg and 135 mg strengths and that it has begun shipping the drug.
The drug is used to treat acne. Sales of Solodyn were $365 million for the 12 months ending Jan. 31, according to IMS Health data.
Teva said it is in patent litigation for the drug in the United States District Court for the District of Delaware, but a trial date has not been set.
Congress introduces new biosimilars bill
WASHINGTON Members of Congress have introduced a second biosimilars bill to compete with the one introduced earlier this month by Democratic Rep. Henry Waxman of California and others.
Reps. Anna Eshoo, D-Calif., Jay Inslee, D-Wash., and Joe Barton, R-Texas, introduced H.R. 1548, the Pathway for Biosimilars Act Tuesday afternoon. The Biotechnology Industry Organization had announced Monday that it expected the bill’s introduction.
While the Waxman bill, the Promoting Innovation and Access to Life-Saving Medicine Act, provides for a five-year market exclusivity period for branded biotech drugs, Eshoo’s bill provides for 12 years of exclusivity.
BIO, which favors an exclusivity period of 14 years, opposed the Waxman bill, describing it as “filled with potholes,” but expressed support for the Eshoo bill.
Pfizer granted patent renewal for Lipitor
NEW YORK Pfizer announced Tuesday that the U.S. Patent and Trademark Office has granted reissue patent RE40667, relating to Lipitor.
The company had applied for the reissue patent in January 2007, in order to correct a technical defect in the ‘995 enantiomer patent for atorvastatin calcium, the salt form of atorvastatin sold as Lipitor.
On Jan. 6, the company announced that the U.S. Patent & Trademark Office had issued a “Notice of Allowance” accepting the company’s application to correct the technical defect in the ‘995 patent.
The reissue patent will have the same force and effect as the original ‘995 patent and the same June 2011 expiration date (including the six-month pediatric exclusivity period).