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$MYL announced the U.S.launch of Estradiol Vaginal Cream, the first generic version of Allergan's Estrace Cream. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of vulvar and vaginal atrophy.
$MYL said the biosimilar Trastuzumab, co-developed by the company and Biocon Ltd. has been approved by ANVISA, the Brazilian regulatory agency, through their partner Libbs Farmaceutica. Trastuzumab is indicated for the treatment of breast cancer and gastric cancer. Libbs will commercialize the product in Brazil under the brand name Zedora.
$MYL announced that Teva has dismissed its pending district court litigation against Mylan regarding Mylan's Glatiramer Acetate Injection 40 mg/mL. Teva dropped litigation on these patents after the U.S. District Court for the District of Delaware issued a decision adopting Mylan's interpretation of the patents' claims.
$MYL and its Johannesburg-listed partner Aspen announced the U.S. launch of Myleran Injection, a busulfan single-dose drug, with Aspen receiving final approval from the FDA for its Abbreviated New Drug Application (ANDA) for this product.
$MYL and India-listed Biocon Ltd announced that the European Medicines Agency (EMA) accepted for review Mylan's Marketing Authorization Applications (MAA) for proposed biosimilar trastuzumab and proposed biosimilar pegfilgrastim. Trastuzumab is used to treat certain HER2-positive breast and gastric cancers.
$MYL announced the U.S. launch of Clofarabine Injection, 20 mg/20 mL Single-Dose Vials, a generic version of Genzyme's Clolar. Mylan received final approval from FDA regarding the drug in the treatment of pediatric patients with relapsed or refractory acute lymphoblastic leukemia.
Pharma company $MYL said it received FDA approval for its Abbreviated New Drug Applications for two variants of Glatiramer Acetate injection, a generic version of $TEVA’s Copaxone - indicated for the treatment of multiple sclerosis. Mylan expects to start shipping of the medicines soon, which will be available by prescription only.
$MYL announced the US launch of Imatinib Mesylate Tablets, a generic version of Novartis's Gleevec Tablets. $MYL received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which has multiple indications, including for several blood cancers.
$MYL announced the US launch of Norethindrone Acetate and Ethinyl Estradiol Tablets USP, and Ferrous Fumarate Tablets, which is indicated for use by women to prevent pregnancy. $MYL’s subsidiary, Mylan Laboratories Limited, received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for this product.
$MYL issued statement on warning letter issued to $PFE's EpiPen auto-injector manufacturing site. Pfizer is continuing to work with the FDA to resolve the points raised in the warning letter regarding Pfizer’s manufacturing of the EpiPen products and Mylan will do whatever it can to support this process.