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Mylan NV (MYL.OQ)

MYL.OQ on NASDAQ Stock Exchange Global Select Market

30.04USD
13 Dec 2018
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Latest Key Developments (Source: Significant Developments)

Aspen On Track To Meet FY Guidance Of Commercial Pharma Organic Revenue Growth
Thursday, 13 Dec 2018 10:30am EST 

Dec 13 (Reuters) - Aspen Pharmacare Holdings Ltd ::ASPEN PHARMACARE HOLDINGS LTD - ON TRACK TO MEET ITS FULL YEAR GUIDANCE OF COMMERCIAL PHARMA ORGANIC REVENUE GROWTH.ASPEN - FY GUIDANCE OF COMMERCIAL PHARMA ORGANIC REVENUE GROWTH RANGING BETWEEN 1% AND 4% BASED ON PERFORMANCE FOR FIVE MONTHS TO 30 NOVEMBER 2018.ASPEN - MANUFACTURING REVENUE FROM APIS HAS DONE BETTER THAN EXPECTED FOR FIVE MONTHS TO 30 NOVEMBER AND IS IN LINE WITH REVENUE FOR COMPARABLE PERIOD.ASPEN PHARMACARE - POSITIVE PERFORMANCE FROM COMMERCIAL PHARMA IN MOST EMERGING MARKETS, JAPAN OFFSET BY WEAKER PERFORMANCE IN EUROPE & RUSSIA IN FY.ASPEN PHARMACARE- SIGNIFICANT PROGRESS MADE IN PROCURING FULFILMENT OF CONDITIONS PRECEDENT TO DISPOSAL TO B.A.S. S.A. OF ASPEN'S NUTRITIONALS BUSINESS.  Full Article

Mylan To Recall All Batches Of Blood Pressure Medicine In U.S.
Tuesday, 4 Dec 2018 11:30am EST 

Dec 4 (Reuters) - Mylan NV ::MYLAN EXPANDS ITS VOLUNTARY NATIONWIDE RECALL OF VALSARTAN TABLETS, USP, AMLODIPINE AND VALSARTAN TABLETS, USP, AND VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP, TO ALL LOTS WITHIN EXPIRY DUE TO THE DETECTION OF TRACE AMOUNTS OF NDEA (N-NITROSODIETHYLAMINE) IMPURITY FOUND IN THE ACTIVE PHARMACEUTICAL INGREDIENT.MYLAN NV - RECALL INCLUDES 104 ADDITIONAL LOTS.  Full Article

Mylan expands gastroenterology portfolio with launch of generic for Prevacid Solutab delayed-release orally disintegrating tablets
Tuesday, 4 Dec 2018 07:30am EST 

Dec 4 (Reuters) - Mylan NV ::MYLAN EXPANDS GASTROENTEROLOGY PORTFOLIO WITH LAUNCH OF GENERIC FOR PREVACID® SOLUTAB DELAYED-RELEASE ORALLY DISINTEGRATING TABLETS.MYLAN NV - U.S. LAUNCH OF LANSOPRAZOLE DELAYED-RELEASE (DR) ORALLY DISINTEGRATING TABLETS (ODT), 15 MG AND 30 MG.  Full Article

FDA Sends Warning Letter Dated Nov. 9 To Mylan Regarding Its Morgantown Facility
Tuesday, 20 Nov 2018 05:43pm EST 

Nov 20 (Reuters) - U.S. Food and Drug Administration::U.S. FDA, IN WARNING LETTER DATED NOV. 9, SAYS INSPECTED MYLAN'S DRUG MANUFACTURING FACILITY AT MORGANTOWN, WEST VIRGINIA, FROM MARCH 19 TO APRIL 12.FDA - CLEANING VALIDATION, VERIFICATION PROGRAM FOR MANUFACTURING EQUIPMENT IN MYLAN'S MORGANTOWN FACILITY INADEQUATE TO PREVENT CROSS CONTAMINATION.FDA - MYLAN'S MORGANTOWN FACILITY HAD MANY INCIDENTS IN WHICH VISIBLE DRUG RESIDUES WERE FOUND ON NON-DEDICATED EQUIPMENT AFTER IT WAS DEEMED CLEAN.FDA, IN NOV. 9 WARNING LETTER ON MYLAN'S MORGANTOWN FACILITY, SAYS INVESTIGATIONS INTO OUT-OF-SPECIFICATION RESULTS & PROCESS DEVIATIONS WERE INADEQUATE.FDA - CHANGES IN BLEND SIZE, FORMULATION, & MANUFACTURE OF DRUG PRODUCTS AT MYLAN'S MORGANTOWN FACILITY WERE NOT EVALUATED CONSISTENTLY.FDA - "STRONGLY RECOMMEND" ENGAGING AN INDEPENDENT THIRD PARTY QUALIFIED AS SET FORTH IN 21 CFR 211.34, TO ASSIST MYLAN IN MEETING CGMP REQUIREMENTS.FDA - UNTIL VIOLATIONS LISTED IN NOV. 9 WARNING LETTER CORRECTED, FDA MAY WITHHOLD APPROVAL OF PENDING DRUG APPLICATIONS LISTING MYLAN'S MORGANTOWN FACILITY.  Full Article

Mylan Initiates Voluntary Nationwide Recall Of 15 Lots Of Certain Valsartan Tablets
Tuesday, 20 Nov 2018 04:10pm EST 

Nov 20 (Reuters) - Mylan NV ::MYLAN INITIATES VOLUNTARY NATIONWIDE RECALL OF 15 LOTS OF VALSARTAN TABLETS, USP, AMLODIPINE AND VALSARTAN TABLETS, USP, AND VALSARTAN AND HYDROCHLOROTHIAZIDE TABLETS, USP, DUE TO THE DETECTION OF TRACE AMOUNTS OF NDEA (N-NITROSODIETHYLAMINE) IMPURITY FOUND IN THE ACTIVE PHARMACEUTICAL INGREDIENT.  Full Article

Mylan Statement In Response To FDA Warning Letter Relating To Morgantown Plant
Tuesday, 20 Nov 2018 02:30pm EST 

Nov 20 (Reuters) - Mylan NV ::MYLAN STATEMENT IN RESPONSE TO FDA WARNING LETTER RELATING TO MORGANTOWN PLANT.MYLAN NV - DID NOT EXPECT TO HAVE ANY SIGNIFICANT NEW PRODUCT LAUNCHES FROM SITE IN 2019.MYLAN NV - IN REGULAR COMMUNICATION WITH FDA, WILL CONTINUE TO WORK TO ENSURE AGENCY IS SATISFIED WITH STEPS TAKEN TO RESOLVE ALL POINTS RAISED.MYLAN NV - NOVEMBER 9 MORGANTOWN LETTER IS SOLE OUTSTANDING FDA WARNING LETTER TO MYLAN.MYLAN NV - ACTIONS HAVE LED TO A TEMPORARY DISRUPTION IN SUPPLY OF CERTAIN MYLAN PRODUCTS FOR CUSTOMERS.MYLAN NV - MORGANTOWN FACILITY CONTINUES TO SUPPLY PRODUCTS FOR U.S. MARKET.MYLAN NV - AS PART OF ONGOING RESTRUCTURING, PROACTIVELY DISCONTINUED NO: OF PRODUCTS FROM SITE WHILE ALSO TRANSFERRING SOME PRODUCTS TO OTHER SITES.MYLAN NV - RESTRUCTURING AND REMEDIATION PLAN AT MORGANTOWN FACILITY REFLECTED IN 2018 OUTLOOK.  Full Article

Theravance, Mylan Expect YUPELRI To Be Available To U.S. COPD Patients Before End Of The Year
Friday, 9 Nov 2018 03:13pm EST 

Nov 9 (Reuters) - Theravance Biopharma Inc ::THERAVANCE BIOPHARMA AND MYLAN RECEIVE FDA APPROVAL FOR YUPELRI™ (REVEFENACIN) IN ADULTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE.THERAVANCE BIOPHARMA INC - CO, MYLAN EXPECT YUPELRI TO BE AVAILABLE TO COPD PATIENTS IN U.S. BEFORE END OF THE YEAR.  Full Article

FDA Approves Theravance Biopharma's COPD Drug Yupelri
Friday, 9 Nov 2018 01:29pm EST 

Nov 9 (Reuters) - U.S. Food And Drug Administration::U.S. FDA - APPROVES THERAVANCE BIOPHARMA'S COPD DRUG YUPELRI.  Full Article

Mylan's Statement On Generic Advair ANDA Status
Monday, 22 Oct 2018 05:50pm EDT 

Oct 22 (Reuters) - Mylan NV ::MYLAN'S STATEMENT ON GENERIC ADVAIR ANDA STATUS.MYLAN ON GENERIC ADVAIR ANDA STATUS - CONFIRMS HAS NOT RECEIVED ANY NEW INFORMATION REQUEST OR CRL FROM FDA.MYLAN ON GENERIC ADVAIR ANDA STATUS SAYS CONTINUES TO BELIEVE THAT FDA APPROVAL IS IMMINENT.  Full Article

Biocon & Mylan Announce Positive CHMP Opinion For Ogivri
Friday, 19 Oct 2018 09:41am EDT 

Oct 19 (Reuters) - Biocon Ltd ::SAYS BIOCON AND MYLAN ANNOUNCE POSITIVE CHMP OPINION FOR OGIVRI, BIOSIMILAR TRASTUZUMAB.  Full Article

South Africa's Aspen strikes distribution deal with U.S. drugmaker Mylan

JOHANNESBURG Aspen Pharmacare has struck a deal with U.S. generics maker Mylan to distribute a portfolio of prescription and over-the-counter drugs in Australia and New Zealand.