NEWS FROM USA
NEW GENERICS LAUNCHES IN US
|
LAUNCH DATE |
DRUG |
COMPANY |
Corresponding RLD |
Annual sales quoted in press release as per IQVIA |
Press Release |
|
3 July 2019 |
Carboprost tromethamine* |
Dr. Reddy’s laboratories (DRL) |
Hemabate (Pfizer) |
$55 Million |
*DRL’s Carboprost tromethamine has received Competitive Generic Therapy (CGT) designation and may receive 180 days exclusivity.
505(b)2 IN PIPELINE:
Oral Parathyroid hormone (PTH) tablet (Entera Bio): Entera Announces Initiation of Phase 2 Dose Ranging Study for Oral PTH
- Entera Bio Ltd., announced that it has initiated a Phase 2 study with its osteoporosis drug candidate EB613, an oral human PTH (1-34) tablet.
- Human PTH (1-34) is a known anabolic treatment currently available as a daily subcutaneous injection, Forteo® (marketed by Eli Lilly®) with a known effect on bone formation biomarkers and bone mineral density (BMD).
- Full Press Release: Link
Liposomal Docetaxel (Cytori pharma): Cytori Reports Summary of FDA Feedback Regarding its albumin stabilized pegylated liposomal Docetaxel (AT-1123)
- Key feedback from the FDA included that a 505(b)(2) application appears to be an acceptable regulatory approach with docetaxel injection as a potentially acceptable LD.
- FDA agreed that the completed nonclinical studies are sufficient to support the initiation of the clinical trial of ATI-1123 in patients with platinum-sensitive small cell lung cancer who have progressed at least 60 days after initiation of first-line therapy.
- Full Press Release: Link
NDA Approval
|
Approval Date |
Product Name |
NDA Sponsor |
Brand Name |
Prescribing information |
|
3 July 2019 |
Selinexor |
KaryoPharm |
Xpovio |
- U.S. Food and Drug Administration (FDA) has approved oral XPOVIOTM (selinexor) in combination with dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody.
- Karyopharm expects XPOVIO to become commercially available in the U.S. on or before July 10, 2019.
- A Marketing Authorization Application for selinexor is also currently under review by the European Medicines Agency.
- Full Press release: Link
GENERIC PATENT LITIGATION
Amphetamine mixed salts - Mydayis (Shire v. KVK-Tech): Shire prevailed in Mydayis patent challenge
- Takeda's Shire plc is the winner of a challenge to two patents protecting long-acting ADHD medicine Mydayis by a would-be generic competitor.
- The USPTO's Patent Trial and Appeal Board ruled that KVK-Tech failed to prove that the patents, covering the method of releasing the drug, are invalid.
- Source: Link
ANDA APPROVALS
|
Approval Date |
Drug Product |
ANDA Sponsor |
Corresponding RLD |
Number Of Other Approved Generics |
|
1 July 2019 |
Amneal |
Hygroton (Sanofi) |
Seven |
|
|
1 July 2019 |
Fresenius Kabi |
Haldol (Janssen) |
Eight |
|
|
1 July 2019 |
Lupin |
Omidria (Omeros) |
None |
|
|
2 July 2019 |
Pii |
Sporanox (Janssen) |
Ten |
|
|
2 July 2019 |
Gage development |
Metrogel-Vaginal (Bausch) |
One (Bausch) |
|
|
2 July 2019 |
Zydus |
Cytotec (GD Searle) |
Two (Novel and ANI) |
|
|
3 July 2019 |
Lupin |
Sensipar (Amgen) |
Eight |
|
|
2 July 2019 |
Polygen pharma |
Ultram (Janssen) |
More than 10 |
*Highlighted product indicate first generic approval for corresponding RLD.
NEWS FROM EUROPE
Dolutegravir/Lamivudine combination tablet (ViiV helathcare): ViiV healthcare receives EU marketing authorisation for dovato (dolutegravir/lamivudine).
- Full Press release: Link
Trastuzumab biosimilar (Prestige biopharma): Mundipharma announces exclusive license and supply agreement with Prestige Biopharma for Tuznue® (Trastuzumab biosimilar).
- Full Press release: Link
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