NEWS FROM USA
NEW GENERICS LAUNCHES IN US
|
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
Ambrisentan Tablets |
Teva |
Letairis |
$247 Million |
|
|
Vancomycin hydrochloride injection |
Hikma |
Vancomycin (Fresenius)-RS |
$247 Million |
Lannett to launch generic Concerta®, AB-rated Methylphenidate Hydrochloride ER Tablets in later Q2 2019.
- Lannett is going to launch Andor’s ANDA product which has received FDA approval in April 2019.
- Total US annual sales of Methylphenidate Hydrochloride ER Tablets were approximately $1.4 billion for the 12 months ended February 2019, according to IQVIA.
- In August 2018, Lannett announced that it entered into a licensing agreement with Andor for Methylphenidate Hydrochloride ER tablets. Under the agreement, Lannett will primarily provide sales, marketing and distribution support of Andor's Methylphenidate ER product, for which it will receive a percentage of the net profits.
- Full Press release: Link
505(B)2 IN PIPELINE:
Fosfomycin injection (Nabriva therapeutics): Nabriva Therapeutics Receives Complete Response Letter from FDA on NDA for Intravenous CONTEPO™ (fosfomycin) for injection.
- The CRL requests that Nabriva address issues related to facility inspections and manufacturing deficiencies at one of Nabriva’s contract manufacturers prior to the FDA approving the NDA.
- Intravenous (IV) fosfomycin has been approved for a number of indications and utilized for over 45 years outside the U.S. to treat a variety of infections, including cUTIs and other serious bacterial infections.
- CONTEPO utilizes a new dosing approach, originally developed by Zavante (which Nabriva Therapeutics acquired), to optimize its pharmacokinetics and pharmacodynamics.
- Full press release: Link
Bupivacaine/Meloxicam fixed dose combination (Heron therapeutics): Heron Therapeutics receives Complete Response Letter for HTX-011 for the management of postoperative Pain.
- The CRL stated that the FDA is unable to approve the NDA in its present form based on the need for additional CMC and non-clinical information.
- HTX-011, which utilizes Heron's proprietary Biochronomer® drug delivery technology, is an investigational, long-acting, extended-release formulation of the local anesthetic bupivacaine in a fixed-dose combination with the anti-inflammatory meloxicam for the management of postoperative pain.
- Full Press release: Link
505(b)2 NDA APPROVALS
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
26 Apr 2019 |
Isopropyl Alcohol Solution |
Zurex |
Zuragard |
|
|
30 Apr 2019 |
Selenious Acid Injection |
American Regent |
Selenious Acid |
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
26 Apr 2019 |
Mylan |
Zetia (MSD) |
More Than 10 |
|
|
26 Apr 2019 |
Par |
Tracleer Tablets (Actelion Pharma) |
Eight |
|
|
26 Apr 2019 |
Alvogen |
|||
|
26 Apr 2019 |
Natco |
|||
|
26 Apr 2019 |
Watson |
|||
|
26 Apr 2019 |
Zydus |
|||
|
26 Apr 2019 |
Lupin |
|||
|
26 Apr 2019 |
Amneal |
|||
|
26 Apr 2019 |
West-Ward |
|||
|
26 Apr 2019 |
Sun Pharma |
|||
|
26 Apr 2019 |
Pii |
K-Tab (Abbvie) |
One (Vitruvias) |
|
|
26 Apr 2019 |
Zydus Pharms |
Syprine (Aton) |
Three |
|
|
26 Apr 2019 |
Sungen Pharma |
Bentyl (Allergan) |
Eight |
|
|
29 Apr 2019 |
Yung Shin |
Felodipine (Astrazeneca) |
More Than 10 |
|
|
29 Apr 2019 |
(2.5mg. 10mg And 20mg) |
Mylan |
Cialis (Lilly) |
More Than 10 |
|
29 Apr 2019 |
(5mg) |
Mylan |
Cialis (Lilly) |
More Than 10 |
|
29 Apr 2019 |
Orient Pharma |
Vancocin Hydrochloride (Ani Pharms) |
Four |
|
|
30 Apr 2019 |
Prinston |
N/A |
Four |
|
|
30 Apr 2019 |
Alvogen |
Nitrostat (Pfizer) |
Four |
|
|
30 Apr 2019 |
Cipla |
Letairis (Gilead) |
Six |
|
|
02 May 2019 |
Alembic Pharma |
Pataday Ophthalmic Solution (Novartis) |
Five |
TENTATIVE ANDA APPROVALS
|
Approval Date |
Drug |
Company |
|
26 Apr 2019 |
Unichem |
OTHER NEWS FROM US:
ViiV Submits NDA for Once-Per-Month HIV Injectable (Cabotegravir+Rilpivirine)
- Full Press release: Link
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