FDA approves NDA for Teva’s topotecan injection
SILVER SPRINGS, Md. — Teva Pharmaceuticals has received approval of their new drug application for topotecan hydrochloride injection, a treatment for small cell lung cancer, according to Food and Drug Administration records.
The NDA provides for the use of topotecan hydrochloride injection in the 1 mg/mL strength in the treatment of chemotherapy-sensitive small cell lung cancer after failure of first-line chemotherapy and, in combination with cisplatin, for the treatment of stage IV-B, recurrent or persistent carcinoma of the cervix, cancer not amenable to curative treatment with surgery or radiation therapy.
As DSN reported in early December, the generic topotecan hydrochloride injection is also produced by Sagent Pharmaceuticals and is a version of GlaxoSmithKline’s Hycamtin.
Perrigo acquires remaining stake in Cobrek Pharmaceuticals
ALLEGAN, Mich. — Solidifying Perrigo’s leadership position in topical foam-based generic prescription pharmaceuticals, the company announced it has signed a definitive merger agreement and completed the acquisition of Cobrek Pharmaceuticals, a privately-held, Chicago-based drug development company, for approximately $45 million.
In 2008, Perrigo acquired a minority 18.5% stake in Cobrek as part of a product development partnership agreement focusing on foam dosage form generic pharmaceutical products. The partnership was responsible for the successful launches of Evoclin (i.e., clindamycin phosphate) Foam 1% and Extina (i.e., ketoconazole) Foam 2%. This newest agreement gives Perrigo an 81.5% share of Cobrek on a cash- and debt-free basis.
The sale precedes Perrigo’s expected fiscal year 2013 commercial launches of FDA-approved generic versions of Luxiq (i.e., betamethasone valerate) Foam and Olux-E (i.e., clobetasol propionate) Foam 0.5%.
FDA approves Mylan’s generic Dilantin chewable tablets
PITTSBURGH — Mylan on Friday announced that its subsidiary, Mylan Pharmaceuticals, has received final approval from the U.S. Food and Drug Administration for its phenytoin chewable tablets USP in the 50 mg strength.
The product is a generic version of Pfizer’s Dilantin Chewable Tablets, which are indicated for the control of generalized tonic-clonic (i.e., grand mal) and complex partial (i.e., psychomotor, temporal lobe) seizures, and prevention and treatment of seizures occurring during or following neurosurgery.
Phenytoin chewable tablets USP 50 mg, had U.S. sales of approximately $16.5 million for the 12 months ending Sept. 30, 2012, according to IMS Health. Mylan is shipping this new product immediately.
Currently, Mylan has 185 Abbreviated New Drug Applications pending FDA approval, representing $80.6 billion in annual sales, according to IMS Health. Thirty-five of these pending ANDAs are potential first-to-file opportunities, representing $21.2 billion in annual brand sales, for the 12 months ending June 30, 2012, according to IMS Health.